MDEDGE.COM/GIHEPNEWS VOL. 13 NO. 7 JULY 2019

®

Cost of physician News from

burnout estimated at in this issue $4.6 billion a year INSIDE

FROM THE AGA BY RICHARD FRANKI look at the system-wide an MDedge News costs of burnout, “provides JOURNALS

innu C tools to evaluate the eco- Tofacitinib upped hysician burnout nomic dimension of this herpes zoster risk

. J ami K The higher daily doses

r costs the U.S. health problem,” wrote Shasha Pcare system approxi- Han, MS, of the National were at issue. • 8 mately $4.6 billion a year University of Singapore

D ourtesy NEWS FROM THE AGA C in physician turnover and and her associates in An- Dr. Jami Kinnucan and the AGA workgroup focused on gaps in IBD reduced productivity, ac- nals of Internal Medicine. AGA’s annual award care related to inflammatory issues, mental health, and nutrition. cording to the results of a Individual burnout-at- winners honored cost-consequence analysis. tributable costs were Reception at DDW In 2015, the burnout- higher for physicians in recognized AGA’s best. • 10 AGA introduces attributable cost per the younger age group physician was $7,600 (less than 55 years) in all LIVER DISEASE – an estimate occupying three specialty categories: AGA Clinical Practice pathway to navigate the conservative mid- $7,100 versus $5,900 for Update dle ground between the those aged at least 55 Coagulation management IBD care $3,700 and $11,000 ex- years among primary care in cirrhosis. • 22 tremes produced by the physicians, $10,800 versus BY HEIDI SPLETE of or diagnosed with IBD study’s mathematical $9,100 for surgical spe- UPPER GI TRACT MDedge News and provide direction on ini- model. cialists, and $7,800 versus Coffee, tea, and soda tiating appropriate patient “Traditionally, the case $6,100 for other special- increase GERD risk nflammatory bowel dis- referrals,” wrote lead author for ameliorating physi- ists, the investigators re- Caffeination did not seem ease (IBD) treatment re- Jami Kinnucan, MD, of the cian burnout has been ported. to matter. • 25 Imains a challenge in part University of Michigan, Ann made primarily on ethi- The mathematical model because care is often frag- Arbor, and members of the cal grounds.” This study, used in the study focused mented among providers in AGA workgroup. believed to be the first to See Burnout · page 28 different specialties, accord- In particular, the pathway ing to the American Gastro- focuses on gaps in IBD care enterological Association. To related to inflammatory FDA warns about fecal microbiota address the need for provid- issues, mental health, and er coordination, the AGA has nutrition. The work group issued a new referral path- included not only gastroen- for transplantation way for IBD care, published terologists, but also a prima- in Gastroenterology. ry care physician, mental/ BY DOUG BRUNK microbiota for transplanta- which was issued on June “The goal of this path- behavioral health specialist, MDedge News tion (FMT) and the risk of 13, 2019, the agency be- way is to offer guidance to registered dietitian/nutri- serious adverse reactions came aware of two im- primary care, emergency tionist, critical care spe- fficials at the Food and because of transmission of munocompromised adult department, and gastroen- cialist, nurse practitioner, ODrug Administration multidrug-resistant organ- patients who received terology providers, by help- physician group representa- have issued a safety alert isms (MDROs). investigational FMT and ing identify patients at risk See IBD · page 15 regarding the use of fecal According to the alert, See Microbiota · page 15

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Presorted Standard Presorted CHANGE SERVICE REQUESTED SERVICE CHANGE GI & Hepatology News Hepatology & GI 2 NEWS JULY 2019 • GI & HEPATOLOGY NEWS LETTER FROM THE EDITOR: Wellness seminars won’t fix burnout

urnout” has been defined ience of our physicians or sending to sacrifice more time and energy must be realistic as long-term, unresolvable us to wellness seminars. That ap- and sit in front of a computer screen. and legal pro- “Bjob stress that leads to proach is a direct blame-the-victim Salvation of our health care sys- tections need exhaustion, depression, and in some paradigm. Physicians are burned out tem will not come from mass retire- strengthening. tragic circumstances, suicide. One because of the constant assault on ments (although that is happening), The politics of of our lead articles this month con- the core reasons we entered med- concierge practices, part-time status, health care has cerns an attempt to place a financial icine – to help people (this assault or other individual responses to this focused on funds DR. ALLEN cost on physician burnout. More has been termed “moral injury”). crisis. We will need a fundamen- flow and ideolo- important, I think, is the toll burnout BPAs (best practice alerts), coding tal reorganization of our practice, gy. We need a stronger voice that ar- takes on an individual, their family, requirements, inbox demands, pri- where we (physicians) reduce our ticulates the daily microaggressions and their patients. In my role as or authorizations (see the practice work to activities for which we that we each endure as we try to live Chief Clinical Officer of the Univer- management section of this issue), trained combined with a shift of Oslerian physician ideals. sity of Michigan Medical Group (our electronic-order entry, and most nonphysician work to others, better faculty and other clinical providers), other practice enhancement tools technology, virtual visits, and ancil- John I. Allen, MD, MBA, AGAF I struggle to balance productivity rely on the willingness of physicians lary personnel. Patient expectations Editor in Chief demands with the increasing dam- age such demands are doing to our clinicians. Few primary care physi- cians at Michigan Medicine work as Quick quiz full-time clinicians (defined as 32 hours patient-facing time per week for 46 weeks). Almost all request Q1: A 70-year-old male presents E. Placement of G tube over-the-counter NSAIDs, breast part-time status if they do not have with progressive dysphagia over cancer (20 years ago treated with protected, grant-funded time. They the past 4 months and 30-pound Q2: A 63-year-old woman is ad- lumpectomy and local radiation); simply cannot keep up with the weight loss. A barium swallow mitted with abdominal pain and and migraines for which she takes documentation required in our elec- demonstrates a dilated esophagus iron deficiency anemia. She re- sumatriptan once or twice a month. tronic health record, combined with with a bird’s beak appearance. ports long-standing anemia and a our “patient-friendly” access via negative work-up in the past year Which medication puts her at the the electronic portal. One-third of What is the next best step? including an upper endoscopy, highest risk for peptic ulcer disease? the private practice group I helped A. Referral for per-oral endoscopic colonoscopy, and video capsule A. Iron build was part-time when I left in myotomy endoscopy. She was started on iron B. Sumatriptan 2012, and it is not unusual to hear B. High-resolution esophageal infusions with a modest improve- C. Alendronate complaints about burnout from my manometry ment in her anemia. Her other med- D. Tamoxifen ex-partners. C. Calcium channel blocker ical history includes osteoporosis; Let’s be clear, burnout is not going D. EGD osteoarthritis, for which she takes The answers are on page 26. to be solved by increasing the resil-

Editor in ChiEf, Gi & hEpatoloGy nEws Gi & hEpatoloGy nEws is the official newspaper of the American frontlinE mEdiCal CommuniCations soCiEty partnErs John I. Allen, MD, MBA, AGAF Gastroenterological Association (AGA) Institute and provides the gastroenterologist VP/Group Publisher; Director, FMC Society Partners Mark Branca Editor in ChiEf, The New GasTroeNTeroloGisT with timely and relevant news and commentary about clinical developments Editor in Chief Mary Jo M. Dales Bryson Katona, MD, PhD and about the impact of health care policy. Content for Gi & hEpatoloGy nEws is developed through a partnership of the newspaper’s medical board of editors Executive Editors Denise Fulton, Kathy Scarbeck assoCiatE Editors Megan A. Adams, MD, JD, MSc (Editor in Chief and Associate Editors), Frontline Medical Communications Inc. Editor Lora T. McGlade Ziad Gellad, MD, MPH, AGAF and the AGA Institute Staff. “News from the AGA” is provided exclusively by the Creative Director Louise A. Koenig AGA, AGA Institute, and AGA Research Foundation. All content is reviewed by the Kim L. Isaacs, MD, PhD, AGAF Director, Production/Manufacturing Rebecca Slebodnik Gyanprakash A. Ketwaroo, MD, MSc medical board of editors for accuracy, timeliness, and pertinence. To add clarity and context to important developments in the field, select content is reviewed by and National Account Manager Artie Krivopal, 973-290-8218, Larry R. Kosinski, MD, MBA, AGAF cell 973-202-5402, [email protected] Sonia S. Kupfer, MD commented on by external experts selected by the board of editors. Digital Account Manager Rey Valdivia, 973-206-8094, [email protected] Wajahat Mehal, MD, PhD The ideas and opinions expressed in Gi & hEpatoloGy nEws do not necessarily Senior Director of Classified Sales Tim LaPella, 484-921-5001, reflect those of the AGA Institute or the Publisher. The AGA Institute and Frontline Editors EmEritus [email protected] Colin W. Howden, MD, AGAF Medical Communications Inc. will not assume responsibility for damages, loss, Advertising Offices 7 Century Drive, Suite 302, Parsippany, Charles J. Lightdale, MD, AGAF or claims of any kind arising from or related to the information contained in NJ 07054-4609 973-206-3434, fax 973-206-9378 this publication, including any claims related to the products, drugs, or services mentioned herein. Advertisements do not constitute endorsement of products on aGa institutE staff the part of the AGA Institute or Frontline Medical Communications Inc. Managing Editor, Gi & hepaToloGy News, Brook A. Simpson FRONTLINE MEDICAL COMMUNICATIONS Managing Editor, The New GasTroeNTeroloGisT, Ryan A. Farrell POSTMASTER Send changes of address (with old mailing label) to GI & Corporate VP, Marketing & Customer Advocacy Senior Publications Coordinator Jillian L. Schweitzer Hepatology News, Subscription Service, 10255 W Higgins Road, Suite 280, SVP, Finance Steven J. Resnick Jim McDonough Director of Publications Lindsey M. Brounstein Rosemont, IL 60018-9914. VP, Operations Jim Chicca VP, Human Resources & Facility Operations Carolyn Caccavelli Vice President of Publications Erin C. Landis RECIPIENT To change your address, contact Subscription Services at 1-800-430- VP, Sales Mike Guire Data Management Director Mike Fritz 5450. For paid subscriptions, single issue purchases, and missing issue claims, VP, Society Partners Mark Branca offiCErs of thE aGa institutE call Customer Service at 1-833-836-2705 or e-mail [email protected] VP, Editor in Chief Mary Jo M. Dales Circulation Director Jared Sonners Corporate Director, Research & Comms. President Hashem B. El-Serag, MD, MPH, AGAF The AGA Institute headquarters is located at 4930 Del Ray Avenue, VP, Editorial Director, Clinical Content Lori Raskin President-Elect M. Bishr Omary, MD, PhD, AGAF Bethesda, MD 20814, [email protected]. Karen Clemments Vice President John M. Inadomi, MD, AGAF Director, Custom Programs Patrick Finnegan Editorial Offices 2275 Research Blvd, Suite 400, Rockville, MD Chief Digital Officer Lee Schweizer Lawrence S. Kim, MD, AGAF Secretary/Treasurer 20850, 240-221-2400, fax 240-221-2548 VP, Digital Content & Strategy Amy Pfeiffer Gi & hEpatoloGy nEws (ISSN 1934-3450) is published monthly for President, Custom Solutions JoAnn Wahl In affiliation with Global Academy for ©2019 by the AGA Institute. All rights reserved. No part of this publication Scan this QR VP, Custom Solutions Wendy Raupers Medical Education, LLC may be reproduced or transmitted in any form or by any means, electronic or $230.00 per year by Frontline Medical Communications Inc., Code to visit mechanical, including photocopy, recording, or any information storage and 7 Century Drive, Suite 302, Parsippany, NJ 07054-4609. mdedge.com/ President David J. Small, MBA retrieval system, without permission in writing from the publisher. Phone 973-206-3434, fax 973-206-9378 gihepnews MDEDGE.COM/GIHEPNEWS • JULY 2019 NEWS 7 FROM THE AGA JOURNALS Atypical food allergies common in IBS

BY AMY KARON For the study, the researchers enrolled patients to which they had tested positive or consumed MDedge News meeting Rome III IBS criteria who tested negative a sham (placebo) diet that excluded only some for common food antigens on immunoglobulin E foods containing the antigen, with a 2-week mong patients with irritable bowel syn- serology and skin tests. During endoscopy, each washout period in between. The CLE-positive drome (IBS) who tested negative for classic patient underwent sequential duodenal challeng- patients showed a 70% average improvement in Afood allergies, confocal laser endomicrosco- es with 20-mL suspensions of wheat, yeast, milk, Francis IBS severity score after 3 months of the py showed that 70% had an immediate disruption soy, and egg white, followed by CLE with biopsy. intervention diet and a 76% improvement at 6 of the intestinal barrier in response to at least one Among 108 patients who finished the study, 76 months. Strikingly, 68% of CLE-positive patients food challenge, with accompanying changes in epi- (70%) were CLE positive. They and their first-de- showed at least an 80% improvement in symp- thelial tight junction proteins and eosinophils. gree relatives were significantly more likely to have toms, while only 4% did not respond at all. Among 108 patients who completed the study, atopic disorders than were CLE-negative patients “Since we do not observe a histological mast 61% showed this atypical allergic response to (P = .001). The most common allergen was wheat cell/basophil increase or activation, and [we] do wheat, wrote Annette Fritscher-Ravens, MD, PhD, of (61% of patients), followed by yeast (20%), milk not find increased mast cell mediators (tryptase) University Hospital Schleswig-Holstein in Kiel, Ger- (9%), soy (7%), and egg white (4%). Also, nine pa- in the duodenal fluid after positive challenge, we many, and her associates. Strikingly, almost 70% of tients reacted to two of the tested food antigens. assume a nonclassical or atypical food allergy as patients with atypical food allergies to wheat, yeast, Compared with CLE-negative patients or con- cause of the mucosal reaction observed by CLE,” milk, soy, or egg white who eliminated these foods trols, CLE-positive patients also had significantly the researchers wrote. Other immune cell param- from their diets showed at least an 80% improve- more intraepithelial lymphocytes (P = .001) and eters remained unchanged, but additional studies ment in IBS symptoms after 3 months. These find- postchallenge expression of claudin-2 (P = .023), are needed to see if these changes are truly ab- ings were published in Gastroenterology. which contributes to tight junction permeability sent or occur later after challenge. The research- Confocal laser endomicroscopy (CLE) “permits and is known to be upregulated in intestinal bar- ers are conducting murine studies of eosinophilic real-time detection and quantification of changes rier dysfunction, IBS, and inflammatory bowel food allergy to shed more light on these nonclas- in intestinal tissues and cells, including increases disease. Conversely, levels of the tight junction pro- sical food allergies. in intraepithelial lymphocytes and fluid extrava- tein occludin were significantly lower in duodenal Funders included the Rashid Hussein Charity sation through epithelial leaks,” the investigators biopsies from CLE-positive patients versus controls Trust, the German Research Foundation, and the wrote. This approach helps clinicians objectively (P = .022). “Levels of mRNAs encoding inflammato- Leibniz Foundation. The researchers reported detect and measure gastrointestinal pathology ry cytokines were unchanged in duodenal tissues having no conflicts of interest. in response to specific foods, potentially freeing after CLE challenge, but eosinophil degranulation IBS patients from highly restrictive diets that ease increased,” the researchers wrote. [email protected] symptoms but are hard to follow, and are not In a double-blind, randomized, crossover study, SOURCE: Fritscher-Ravens A et al. Gastroenterology. 2019 meant for long-term use. patients then excluded from their diet the antigen May 14. doi: 10.1053/j.gastro.2019.03.046. Endoscopist personality linked to adenoma detection rate

BY AMY KARON that performing a meticulous exam- for differences among patient pop- also were significantly higher among MDedge News ination is mentally taxing and can ulations. Next, the researchers sur- physicians who described them- cause a physician to feel rushed or veyed the physicians who performed selves as more thorough than their ndoscopists who described perceive that it is difficult to keep the endoscopies about their finan- peers, who said they felt rushed Ethemselves as “compulsive” and pace or accomplish goals,” the re- cial motivations, knowledge and per- during endoscopy, and who reported “thorough” had significantly higher searchers wrote. ceptions of colonoscopy quality, and having difficulty pacing themselves, rates of adenoma detection, accord- Adenoma detection rates vary personality traits. accomplishing goals, or managing ing to results from a self-reported widely among physicians – up Among 117 physicians surveyed, unforeseen situations. survey of 117 physician endosco- to threefold in some studies. Re- the median risk-adjusted adenoma A secondary analysis revealed pists. searchers have failed to attribute detection rate was 29.3%, with the same links between personality Financial incentives, malpractice most of this discrepancy to seem- an interquartile range of 24.1%- traits and adenomas per colonosco- concerns, and perceptions of ad- ingly obvious factors such as the 35.5%. “We found no significant py. The findings support an expert’s enoma detection rate as a quality type of specialty training an endos- association between adenoma prior assertion (Gastrointest En- metric were not associated with copist completes. The traditional detection rate and financial in- dosc. 2007 Jan;65[1]:145-50) that endoscopists’ detection rates in the fee-for-service payment model is centives, malpractice concerns, or the best endoscopists are “slow, survey. likely a culprit since physicians are physicians’ perceptions of adenoma careful, and compulsive,” the re- “Adenoma detection rates were paid for performing as many colo- detection rate as a quality metric,” searchers noted. They recommend- higher among physicians who de- noscopies as possible rather than the researchers wrote. ed nurturing “meticulousness and scribed themselves as more com- for procedural quality. Other poten- In contrast, endoscopists who de- attention to detail” during training pulsive or thorough, and among tial variables include personality scribed themselves as either much and evaluating trainees based on those who reported feeling rushed traits and endoscopists’ knowledge or somewhat more compulsive than these characteristics. or having difficulty accomplishing and views on the importance of ad- their peers had significantly higher The National Cancer Institute goals,” Ghideon Ezaz, MD, of Beth enoma detection rates. median adjusted rates of adenoma provided funding. The researchers Israel Deaconess Medical Center To examine the roles of these fac- detection than did endoscopists who reported having no conflicts of in- in Boston and associates wrote in tors in adenoma detection rates, Dr. described themselves as about the terest. Clinical Gastroenterology and Hepa- Ezaz and coinvestigators used elec- same or somewhat less compulsive tology. tronic health records data from four than others. These adenoma detec- [email protected] These feelings were related to health systems in Boston, Pittsburgh, tion rates, in respective order, were SOURCE: Ezaz G et al. Clin Gastroenterol withdrawal times rather than daily North Carolina, and Seattle. Detec- 33.1%, 32.9%, 26.4%, and 27.3% (P Hepatol. 2018 Oct 13. doi: 10.1016/j. procedure volume. “We hypothesize tion rates were adjusted to control = .0019). Adenoma detection rates cgh.2018.10.019. 8 NEWS JULY 2019 • GI & HEPATOLOGY NEWS FROM THE AGA JOURNALS Tofacitinib upped herpes zoster risk in ulcerative colitis

BY AMY KARON apy) followed by 5 or 10 mg twice daily (mainte- integrin receptor antagonist), and anti–tumor ne- MDedge News nance). The safety of tofacitinib has been studied in crosis factor agents in UC, the researchers wrote. patients with rheumatoid arthritis through 9 years There were four deaths during the entire to- mong patients with moderate to severe ul- of treatment. To begin a similar undertaking in UC, facitinib UC program, for an incidence rate of 0.2 cerative colitis (UC), a median of 1.4 years Dr. Sandborn and associates pooled data from three per 100 person-years of exposure. All occurred Aand up to 4.4 years of tofacitinib therapy 8-week, double-blind, placebo-controlled induction in patients receiving 10 mg twice daily. Causes of was safe apart from a dose-related increase in trials, as well as one 52-week, double-blind, place- death were dissecting aortic aneurysm, hepatic risk of herpes zoster infection, according to an in- bo-controlled maintenance trial and one ongoing angiosarcoma, acute myeloid leukemia, and pul- tegrated analysis of data from five clinical trials. open-label trial. All patients received twice-daily monary embolism in a patient with cholangiocar- Compared with placebo, a 5-mg twice-daily tofacitinib (5 mg or 10 mg) or placebo. cinoma that had metastasized. Concerns about maintenance dose of tofacitinib (Xeljanz) produced In 1,157 tofacitinib recipients in the pooled anal- pulmonary embolism have led the European a 2.1-fold greater risk of herpes zoster infection ysis, 84% received an average of 10 mg twice daily. Medicines Agency to recommend against the use (95% confidence interval, 0.4-6.0), while a 10-mg, For every 100 person-years of tofacitinib exposure, of 10-mg twice daily tofacitinib dose in patients twice-daily dose produced a statistically significant there were an estimated 2.0 serious infections, 1.3 at increased risk for pulmonary embolism. 6.6-fold increase in incidence (95% CI, 3.2-12.2). opportunistic infections, 4.1 herpes zoster infec- “Compared with prior experience with tofaci- Except for the higher incidence rate of herpes tions, 1.4 malignancies (including nonmelanoma tinib in rheumatoid arthritis, no new or unexpect- zoster, “in the overall cohort, the safety profile of skin cancer, at an incidence of 0.7), 0.2 major ed safety signals were identified,” the researchers tofacitinib was generally similar to that of tumor cardiovascular events, and 0.2 gastrointestinal concluded. “These safety findings support the long- necrosis factor inhibitor therapies,” wrote William perforations. The likelihood of these events did not term use of tofacitinib 5 and 10 mg twice daily in J. Sandborn, MD, AGAF, director of the inflamma- increase with time on tofacitinib. patients with moderately to severely active” UC. tory bowel disease center and professor of med- Worsening UC was the most common serious Pfizer makes tofacitinib, funded the individual icine, at the University of California, San Diego, adverse event for patients who received both in- trials, and paid for medical writing. Dr. Sandborn and associates. The findings were published in duction and maintenance therapy. For patients on disclosed grants, personal fees, and nonfinancial Clinical Gastroenterology and Hepatology. maintenance therapy, only herpes zoster infec- support from Pfizer and many other pharmaceu- Tofacitinib is an oral, small-molecular Janus ki- tion had a higher incidence than placebo, which tical companies. nase inhibitor approved in the United States for reached significance at the 10-mg dose. These safe- moderate to severe UC, as well as rheumatoid and ty findings resemble those in rheumatoid arthritis [email protected] psoriatic arthritis. The recommended UC dose is 10 trials of tofacitinib, and apart from herpes zoster, SOURCE: Sandborn WJ et al. Clin Gastroenterol Hepatol. mg twice daily for at least 8 weeks (induction ther- they also resemble safety data for vedolizumab (an 2018 Nov 23. doi: 10.1016/j.cgh.2018.11.035.

s new mechanisms of action be- patients being started on tofacitinib. recently forbade the use of the 10-mg tofacitinib Acome available for ulcerative colitis However, there is a theoretical risk of dose for anyone at increased risk for VTE. It is un- (UC) drugs, clinicians must weigh the disease exacerbation; ongoing studies clear if this risk applies to those younger than 50 risks versus benefits. In this article, will hopefully answer this question. years without cardiovascular risk factors or the UC Sandborn and colleagues provide addi- Another emerging safety concern population. In the current study of UC patients, the tional information on the safety profile with tofacitinib involves venous throm- rate of a major cardiovascular event was rare (n = of tofacitinib. They report an increased boembolism (VTE). The Food and Drug 4; IR, 0.2). In the short term, it may be prudent to risk of herpes zoster that was dose Administration recently issued a warn- restrict the 10-mg twice-daily dose to those who dependent (sixfold increase on 10 mg ing based on the findings of a safety do not fall into the high-risk category, or try to re- twice daily). The overall safety profile trial in rheumatoid arthritis in which duce the dose to 5 mg twice daily if possible. was reassuring, is similar to the rheu- DR. SCHWARTZ they found an increased risk of PE and matoid arthritis population treated with death in those on a 10-mg twice-daily David A. Schwartz, MD, AGAF, professor of medi- tofacitinib, and is in line with the safety profile dose. The exact details of the risk have yet to be cine, division of gastroenterology, hepatology and of anti-TNF antibodies (excluding the increased released. Enrollment in the trial required patients nutrition, Inflammatory Bowel Disease Center, risk of zoster). With a nonlive zoster vaccine now aged over 50 years with at least one cardiovas- Vanderbilt University, Nashville. He has served as a available, some have advocated vaccinating all cular risk factor. The European regulatory body consultant for Pfizer in the past.

Inducible nitric oxide synthase promotes insulin resistance in obesity

BY AMY KARON mation and lysosome dysfunction treatments for metabolic diseases. cirrhosis, and alpha 1-anti-trypsin MDedge News coexist in the liver,” wrote Qing- Lysosomes recycle autophagocy- disorder, the researchers wrote. But wen Qian, PhD, of the University of tosed intracellular and extracellular it was unclear whether NO in hepato- besity promotes the localization Iowa in Iowa City and associates material, which is crucial to main- cytes was generated by local iNOS or Oof inducible nitric oxide synthase in Cellular and Molecular GI and tain several types of homeostasis localized to lysosomes. (iNOS) in hepatic lysosomes, leading Hepatology.“Our studies suggest within the liver; they help regulate The researchers therefore stud- to a cascade of downstream effects that lysosomal iNOS-mediated NO nutrient sensing, glycogen metab- ied cell cultures of primary murine that include excess lysosomal NO signaling disrupts hepatic lysosom- olism, cholesterol trafficking, and hepatocytes by measuring their production, reduced hepatic autoph- al function, contributing to obe- viral defense. lysosomal activity, autophagy levels, agy, and insulin resistance, investiga- sity-associated defective hepatic Activation of iNOS is a hallmark of and NO levels. tors reported. autophagy and insulin resistance.” inflammation, and iNOS levels are They also studied a murine mod- “It is well known that in the They noted that the findings could known to be elevated in the livers of el of diet-induced obesity in which context of obesity, chronic inflam- hasten the development of new patients with hepatitis C, alcoholic Continued on following page MDEDGE.COM/GIHEPNEWS • JULY 2019 NEWS 9 FROM THE AGA JOURNALS Continued from previous page genesis by activating TFEB, enhanced lysosomal function and autophagy, and nderstanding the mechanisms for how 60% of calories were from fat. They per- improved hepatic insulin sensitivity. Uobesity affects cellular pathways is formed glucose tolerance tests by means Insulin sensitivity diminished, however, critical for identifying therapeutic targets of intraperitoneal glucose injections and when the researchers suppressed TFEB to prevent its adverse consequences. Qian studied the effects of insulin infusion. or autophagy-related 7 (Atg7). et al., through a well-designed series of Finally, they performed immunohistology, Usually, iNOS is primarily expressed experiments conducted in a mouse model immunohistochemistry, electron micros- in hepatic Kupffer cells, but obesity of diet-induced obesity, demonstrate local- copy, and measurements of nitrosylated increases the expression of iNOS in ization of inducible nitric oxide synthase proteins and lysosomal arginine in frozen hepatocytes, which promotes hepatic (iNOS) to lysosomes in the livers of obese liver sections from the mice. Lysosomal insulin resistance and inflammation, animals. This triggers excess local NO gen- DR. DIWAN arginine is required to catalyze NO pro- the researchers commented. “Neverthe- eration, which leads to excessive nitrosyla- duction in the setting of inflammation as less, our data showed that liver-specific tion of lysosomal proteins. observed in obesity. In fact, concomitant iNOS suppression has a protective role,” A direct consequence of the resultant lysosome dysfunction stimulation of lysosomal arginine trans- they wrote. “We showed that iNOS in- is impaired autophagy, which is a critical cellular pathway for port and activation of mTOR (an enzyme activates [TFEB], and that suppression clearing away damaged organelles and proteins and generating which tightly regulates transcription fac- of [TFEB] and Atg7 diminishes the energy under nutrient stress. Their studies also implicate lyso- tor EB [TFEB]) was sufficient to stimulate improved hepatic insulin sensitivity by somal NO generation in suppressing the activity of transcription lysosomal NO production in hepatocytes iNOS deletion.” TFEB both regulates factor EB, a master regulator of autophagy and lysosome biogen- even in the absence of an inflammatory autophagy and is a “key player in lipid esis. Remarkably, genetic ablation of iNOS prevents the lysosome stimulus; pointing to a central role for metabolism,” they added. dysfunction and autophagy impairment, to attenuate obesity-in- these processes. Funders included the American Heart duced insulin resistance. Future studies will be required to as- The researchers found that a NO scav- Association, American Diabetes Associ- sess the mechanisms for iNOS localization to the lysosomes and enger diminished lysosomal NO produc- ation, and National Institutes of Health. its interplay with the mammalian target of rapamycin (mTOR) tion, while overexpression of both mTOR The researchers reported no conflicts of signaling pathway in the face of sustained nutrient excess. and a lysomal arginine transporter interest. upregulated lysosomal NO production Abhinav Diwan, MD, is an associate professor of medicine, cell biolo- and suppressed autophagy. In mice with [email protected] gy, and physiology at Washington University and associate division diet-induced obesity, deleting iNOS also SOURCE: Qian Q et al. Cell Molec Gastro- chief of cardiology at the John Cochran VA Medical Center, both in St. improved nitrosative stress in hepatic enterol Hepatol. doi: 10.1016/j.jcmgh.2019 Louis. He has no conflicts. lysosomes, promoted lysosomal bio- .03.005. Not eating red, processed meat did not prevent CD flares

BY AMY KARON effect, all patients were told to MDedge News drink at least 16 ounces of water or understandable reasons, many Dietary intervention studies are daily. Each week, patients were Fpatients believe that their symp- notoriously difficult to perform; or adults with Crohn’s disease in emailed a web-based survey of toms or gastrointestinal disorders what is remarkable was that the Fremission at baseline, eating red disease status and dietary adher- emanate from some interaction investigators were able to com- and processed meat no more than ence. At baseline and during six with a component of their plete the study with high once per month did not reduce risk other weeks, they also received diet. Crohn’s disease is no rates of compliance over of relapse in a randomized control a daily survey of disease activity exception; various dietary almost a year! Whether trial. and current medications. The factors have been incrim- dietary patterns ear- After 49 weeks, there were no primary outcome was symptom- inated in disease patho- lier in life (when the significant differences in time to atic relapse, defined as at least genesis and the induction microbiota is more sus- relapse, time to moderate or se- a 70-point rise such that sCDAI of relapse among those ceptible) or over longer vere relapse, or time to persistent score exceeded 150, surgery for already affected. Further- periods could affect the relapse between the low- and high- Crohn’s disease flare, or self-re- more, a number of dietary natural history of inflam- meat groups, reported Lindsey G. ported initiation or dose increase strategies or interventions matory bowel disease re- Aldenberg, DO, of the Children’s of mesalamine, thiopurine, metho- have been recommended DR. QUIGLEY mains to be determined. Hospital of Philadelphia and coin- trexate, corticosteroid, anti–tumor as therapeutic. For the For now, this study has vestigators. The findings were pub- necrosis factor–alpha therapy, or induction of relapse, meat and relat- shown us that high-quality dietary lished in Gastroenterology. natalizumab. ed dietary components, such as fat, studies can be performed and that The randomized study included In all, 78% (166) of patients have been primary suspects. variations in meat intake, within 213 adults with Crohn’s disease either completed the study or This association was examined in the range of those likely to occur in whose short Crohn’s Disease Ac- experienced an outcome. Symp- this study by comparing the effects real life, do not affect relapse rates tivity Index (sCDAI) score was tomatic relapse occurred in 62% of low- or high-meat intakes (red in Crohn’s disease. 150 or less at baseline and who of these 166 patients, while 42% meat and processed meat) over consumed red meat at least once and 35% had moderate to severe 49 weeks on clinical relapse rates Eamonn M. Quigley, MD, is the David weekly. They were instructed to relapses, respectively. “There were in Crohn’s patients in remission M. Underwood Chair of Medicine in consume one serving (3 ounces) no significant differences in time at baseline. Sixty-two percent re- Digestive Disorders, Institute for Ac- of red meat or any processed to relapse for any of the outcomes,” lapsed, and 42% had a moderate to ademic Medicine; director, Lynda K. (smoked, salted, or otherwise pre- the researchers wrote. Results were severe relapse. However, there was and David M. Underwood Center for served) meat at least twice weekly similar when they assumed that pa- no difference in time to relapse or Digestive Disorders, Houston Method- (high-meat group) or no more tients who completed no surveys all rates of moderate/severe relapse ist Hospital. He has no relevant con- than once monthly (low-meat relapsed at week 1. between the two dietary groups. flicts of interest. group). To create a placebo-like Continued on following page 10 NEWS FROM THE AGA JULY 2019 • GI & HEPATOLOGY NEWS AGA honors annual award winners at DDW reception he annual AGA Recognition Achievement Award in Basic Sci- future gastroenterologists, nurses mentoring of trainees in the field of Awards honor the achievements ence for work that has significantly and physician assistants. gastroenterology and for achieve- Tof innovators and leaders in advanced the science and practice Dr. Proctor currently serves as the ments as an outstanding mentor gastroenterology. During a reception of gastroenterology. Dr. Greenberg’s AGA Institute Education & Training throughout a career. Dr. Gorelick has at Digestive Disease Week® (DDW), contributions over several decades Councillor. She is professor of medi- been an inspiration to generations of AGA celebrated members who con- contributed to the development of cine and the medical director of the trainees, many of whom have gone tribute to the profession. rotavirus vaccines and an increased inflammatory bowel disease program on to successful academic careers as “AGA members honor their col- understanding of viral pathogene- at the Yale School of Medicine, New faculty members, section chiefs, pro- leagues and peers for outstanding sis, particularly rotavirus, norovirus Haven, Conn. gram directors, department chairs, contributions to the field of gastro- and hepatitis. Dr. Greenberg is an and institute directors. Dr. Gorelick enterology by nominating them for associate dean for research at the Distinguished Clinician Awards is professor of medicine and cell bi- the AGA Recognition Awards,” said Stanford University School of Medi- The AGA Distinguished Clinician ology at Yale School of Medicine and AGA Institute Past President David A. cine, Palo Alto, Calif. Awards honor members of the prac- deputy director of the Yale MD, PhD Lieberman, MD, AGAF. ticing community who, by example, Program, New Haven, Conn. William Beaumont Prize combine the art of medicine with Julius Friedenwald Medal in Gastroenterology the skills demanded by the scientif- Research Service Award AGA awarded its highest honor to AGA awarded Timothy C. Wang, MD, ic body of knowledge in service to Ann G. Zauber, PhD, received the John I. Allen, MD, MBA, AGAF, for AGAF, the William Beaumont Prize their patients. Research Service Award, which contributions to the field of gastro- in Gastroenterology, which recog- AGA presented the Distinguished honors individuals whose work enterology and to AGA that span nizes an individual who has made Clinician Award, Private Prac- has significantly advanced gastro- decades. The Julius Friedenwald a unique, outstanding contribution tice, to Naresh T. Gunaratnam, MD, enterological science and research. Medal, presented annually since of major importance to the field of AGAF. Dr. Gunaratnam has made a Dr. Zauber’s accomplishments have 1941, recognizes a physician for gastroenterology. Dr. Wang’s contri- significant impact on patient care changed and advanced the practice lifelong contributions to the field of butions to the understanding and in his community and improved of gastroenterology. Her research gastroenterology. practice of modern gastroenterology gastroenterology-oncology care by involving colorectal cancer screen- Dr. Allen is internationally re- and digestive science are exempli- creating the Endoscopic Ultrasound ing and surveillance studies has had nowned for bringing unique and fied through his work, which in- & Interventional GI Program at St. far-reaching effects on public policy. critical knowledge about health care cludes defining the mechanisms and Joseph Mercy Ann Arbor Hospital in She is well known for her leadership delivery and health care econom- cellular origins of Barrett’s esopha- Ypsilanti, Mich. Dr. Gunaratnam is di- role in the development of co- ics to the field of gastroenterology, gus and gastroesophageal cancer. rector of research and obesity man- lorectal cancer screening guidelines, as well as for his decades of AGA Dr. Wang has served AGA in nu- agement at Huron Gastro, Ypsilanti. which have significantly reduced leadership. His experience includes merous positions, including as pres- AGA presented the Distinguished mortality and incidence rates. Dr. private practice, nonacademic health ident of the AGA Institute, is chief Clinician Award, Clinical Academ- Zauber is attending biostatistician in systems, and leadership within two of the division of digestive and liver ic Practice, to Edward V. Loftus Jr., the department of epidemiology and academic medical centers. diseases at the Columbia University MD, AGAF. Dr. Loftus is recognized biostatistics at Memorial Sloan Ket- As AGA Institute President, Dr. Medical Center and the Dorothy L. as a role model in practice and an tering Cancer Center, New York. Allen led the development of AGA’s and Daniel H. Silberberg Professor effective researcher. He’s known for 5-year strategic plan and made AGA of Medicine at the Columbia Univer- his devotion to treating patients with Young Investigator Award a national player at the federal, state, sity Vagelos College of Physicians ulcerative colitis and Crohn’s disease The AGA Young Investigator Award and local levels in a time of massive and Surgeons, New York. with high-quality clinical care, in- recognizes two young investiga- health care delivery transformation. cluding understanding the predictors tors, one in basic science and one He is clinical professor of medicine in Distinguished Educator Award of treatment response. Dr. Loftus is in clinical science, for outstanding the division of gastroenterology and AGA recognized Deborah D. Proctor, a practicing gastroenterologist and research achievements. hepatology and chief clinical officer MD, AGAF, with the Distinguished professor of medicine at the Mayo AGA honored Sonia S. Kupfer, MD, of the University of Michigan Medical Educator Award, which honors an Clinic College of Medicine and Sci- with the Young Investigator Award Group at the University of Michigan individual who has made outstand- ence, Rochester, Minn. in Clinical Science. Dr. Kupfer is School of Medicine, Ann Arbor. ing contributions as an educator nationally and internationally rec- in gastroenterology on the local Distinguished Mentor Award ognized as an expert in colorectal Distinguished Achievement and national level. Dr. Proctor is a The Distinguished Mentor Award was cancer in high-risk populations, such Award in Basic Science national expert in gastroenterolo- presented to Fred S. Gorelick, MD. as individuals with hereditary cancer AGA honored Harry B. Greenberg, gy training and education who has The award recognizes an individual syndromes and African Americans. MD, with the AGA Distinguished taught and inspired generations of who has made contributions to the During her clinical and translation-

Continued from previous page red or processed meat during 57.3% of weeks. A of improving Crohn’s disease outcomes, although logistic regression model showed that the high- there may be some benefit for other health condi- At week 20, median fecal calprotectin levels were meat group was much more likely to consume a tions,” Dr. Aldenberg and associates concluded. higher in the high-meat arm (74.5 mcg/g) than in least two servings of red or processed meat in The Crohn’s and Colitis Foundation and the the low-meat arm (36.0 mcg/g), but the difference the prior week than the low-meat group (P less National Institutes of Health supported the was not statistically significant. Proportions of pa- than .0001). Approximately 90% of patients in work. Dr. Aldenberg disclosed receiving research tients with fecal calprotectin levels above 150 or both arms drank the recommended amount of funding from Seres Therapeutics. Two of six co- 250 mcg/g also did not significantly differ between water. investigators disclosed ties to Nestle Health Sci- arms. Study participants were part of IBD Partners, ence, AbbVie, Pfizer, Eli Lilly, and several other Adherence to the diets was reasonable: Pa- an Internet-based cohort of more than 15,000 pa- pharmaceutical companies. tients in the high-meat group reported consum- tients with inflammatory bowel disease. ing at least two servings of red or processed “Based on these results, there is insufficient [email protected] meat during 98.5% of weeks, while patients in evidence to recommend reduction of red and pro- SOURCE: Aldenberg LG et al. Gastroenterology. 2019 Mar the low-meat arm completely abstained from cessed meat consumption solely for the purpose 11. doi: 10.1053/j.gastro.2019.03.015. MDEDGE.COM/GIHEPNEWS • JULY 2019 NEWS FROM THE AGA 11 al research to better understand matory Bowel Diseases University of North Carolina School Fred S. Gorelick, MD factors that increase the risk of col- Edward V. Loftus Jr., MD, AGAF of Medicine, Chapel Hill West Haven VA Medical Center, Conn. orectal cancer, Dr. Kupfer identified Mayo Clinic, Rochester, Minn. • Neurogastroenterology & Motility • Pediatric Gastroenterology & Devel- distinctions in the African American • Liver & Biliary Gianrico Farrugia, MD, AGAF opmental Biology population compared with whites. David A. Brenner, MD Mayo Clinic, Jacksonville, Fla. Anne Marie Griffiths, MD Dr. Kupfer is director of the Gastroin- University of California San Diego • Obesity, Metabolism & Nutrition The Hospital for Sick Children, To- testinal Cancer Risk and Prevention School of Medicine, Calif. Kelly A. Tappenden, PhD, RD ronto Clinic and associate professor of • Microbiome & Microbial Therapy University of Illinois, Chicago medicine at the University of Chicago. R. Balfour Sartor, MD • Pancreatic Disorders [email protected] AGA honored Costas A. Lyssiotis, PhD, with the Young Investigator Award in Basic Science. His re- search, work ethic, and innovative approaches have made him a distin- guished leader in the study of pan- creatic cancer. His work has broad implications for harnessing the pow- ® er of the immune system to treat dis- ease, and his laboratory is working Make ACTIVIA to develop drug therapies that target a pancreatic cancer metabolism-spe- cific enzyme. Dr. Lyssiotis is assistant your probiotic choice. professor in the department of mo- lecular and integrative physiology in the division of gastroenterology at the University of Michigan Medical School, Ann Arbor.

2019 Research Mentor Award The AGA Institute also presented Council Section Research Mentor Awards during section-sponsored sessions at DDW®. These awards recognize AGA members for their achievements as outstanding men- tors in a specific area of research. Here are the 2019 Research Mentor Award recipients: • Basic & Clinical Intestinal Disorders Wayne I. Lencer, MD, AGAF Harvard Medical School Pediatrics, Boston, Mass. Consume twice a day. • Cellular & Molecular Gastroenter- ology Mark Donowitz, MD, AGAF There are several reasons why your patients should get probiotics from food: Hopkins Center for Epithelial Disor- •Probiotic foods can buffer stomach acids and increase the chance that the probiotics survive and make it to the intestine. ders, Hopkins NIH Conte Digestive •Probiotic supplements in the form of pills don’t usually provide nutrients that some cultures produce during fermentation. Diseases Basic & Translational Re- •Fermented dairy products, like yogurt, are a source of nutrients such as calcium, protein, and potassium. search Core Center, Johns Hopkins •Some individuals have trouble swallowing, or just don’t like pills; but yogurt is easy and enjoyable to consume. University School of Medicine, Balti- Forest plot of composite score of the frequency of minor digestive issues. more, Md. LSmeans = least squares means; CI = confidence interval; N = number of subjects that ACTIVIA may help reduce the frequency of minor • Clinical Practice completed the study; test for heterogeneity P > 0.10; test for overall effect P = 0.003. digestive discomfort.* LSmeans and 95% CI LSmeans 95% CI N Linda Rabeneck, MD, MPH Study 1 Two double-blind, randomized, placebo-controlled studies, and a pooled analysis of 2 Weeks – 0.64 [–1.23; –0.05] Cancer Care Ontario, University of 199 these studies, show that ACTIVIA may help reduce the frequency of minor digestive 4 Weeks – 0.64 [–1.19; –0.08] discomfort like bloating, gas, abdominal discomfort, and rumbling.1,2* Toronto Study 2 2 Weeks – 0.43 [–0.82; –0.05] 336 Both studies were designed to investigate the effect of ACTIVIA on different gastrointestinal • Esophageal, Gastric & Duodenal 4 Weeks – 0.41 [–0.79; –0.02] Pooled (GI) outcomes, including GI well-being and frequency of minor digestive discomfort, Disorders analysis 2 Weeks – 0.50 [–0.82; –0.17] in healthy women. Stuart Jon Spechler, MD, AGAF 535 4 Weeks – 0.48 [–0.80; –0.16] In both studies, and in the pooled analysis, the composite score of the frequency of minor Baylor University Medical Center 3 1,2 –1.50 –1.25 -1.00 –0.75 -0.50 -0.25 0.00 0.25 0.50 digestive issues over the two- and four-week test periods in the ACTIVIA group was at Dallas; Center for Esophageal Favors ACTIVIA® Favors control product 2 Weeks 4 Weeks significantly lower (P<0.05) than that in the control group. Research Baylor Scott & White Re- search Institute, Dallas, Tex. *Consume twice a day for two weeks as part of a balanced diet and healthy lifestyle. Minor digestive discomfort includes bloating, gas, abdominal discomfort, and rumbling. • Gastrointestinal Oncology 1. Guyonnet et al. Br J Nutr. 2009;102(11):1654-62. 2. Marteau et al. Neurogastroenterol Motil. 2013;25(4):331-e252. 3. Marteau et al. Nutrients. 2019;11(1):92. Richard M. Peek Jr., MD, AGAF ©2019 Danone US, LLC. Vanderbilt University School of Medicine, Nashville, Tenn. • Imaging, Endoscopy & Advanced Recommend ACTIVIA. Visit www.activiareferralpad.com Technology to order your referral pad today. Offer available to healthcare professionals only. Irving Waxman, MD University of Chicago, Ill. • Immunology, Microbiology & Inflam- 12 NEWS FROM THE AGA JULY 2019 • GI & HEPATOLOGY NEWS Washington makes low Physician innovator working drug prices a priority to bring new tech to patients,

he House of Representatives for the product. The rule takes ef- thanks to AGA funding passed two bills aimed at fect in 60 days and the drug indus- he AGA Research Foundation’s times a month to drain the fluid, Tspeeding up the development try opposes the rule, which they career development awards which could weigh as much as 10 of generics and biosimilars while say could sway patients away from Tare invaluable tools for ear- pounds or more. Refractory ascites the Trump administration finalized certain medications and lead to ly-career investigators to advance is stubbornly resistant to standard a rule to require drug companies more misinformation on the actual their careers in gastroenterology medical therapy. The only definitive to list the price of their products in costs. and hepatology research. When treatment is liver transplantation. their television ads. House Appropriations Committee Ashish Nimgaonkar, MD, Dr. Nimgaonkar was able The House passed two bills to approves $2 billion NIH increase. MTech, MS, received the to combine his dual train- address drug pricing. The House The House Appropriations Com- AGA-Boston Scientific ing in gastroenterology passed H.R. 1503, the Orange Book mittee approved their fiscal year Career Development and in medical technology Transparency Act of 2019, legisla- 2020 Labor, HHS, and Education Technology and Innova- innovation through the tion that would make changes to Appropriations bill that includes tion Award in 2014, he biodesign program at the FDA’s “orange” book to provide a $2 billion increase in NIH fund- was able to step up his Stanford (Calif.) University, better information on brand drug ing. The Committee also includes research and develop a along with the breadth of and patent exclusivity. The orange critical report language on several new technological ap- engineering and research book is used by doctors and phar- GI research areas including inflam- proach for managing pa- expertise at Johns Hopkins macists for information on generic matory bowel disease, colorectal tients with chronic liver DR. NIMGAONKAR University, to develop a drug approvals and availability. It cancer screenings, early-onset disease–related compli- bio-powered shunt that is also used by generic drug man- colorectal cancer, and the role of cations. moves a patient’s fluid buildup out of ufacturers to make decisions on food as medicine in treating diseas- We are delighted to introduce the peritoneal cavity to the urinary where to invest in research and de- es. The bill also includes important you to the work of Dr. Nimgaonkar, bladder, where it can be eliminated velopment as it provides informa- language directing CMS to require medical director in the Johns Hop- naturally. His shunt has another tion on the exclusivity period for Medicare Advantage plans to ex- kins Center for Bioengineering major advantage for patients who brand name drugs. Similarly, the clude from prior authorization re- Innovation and Design, department are on liver transplant lists and are House passed H.R. 1520, the Pur- quirements those services that align of biomedical engineering, and an required to undergo MRI and other ple Book Continuity Act, legislation with evidence-based guidelines and assistant professor of medicine and diagnostics: It contains no metal that would update FDA’s “purple” have a high prior authorization ap- business at Johns Hopkins Univer- components. book on patents and exclusivity for proval rate. The language also calls sity. Read more and get to know Dr. biologics. These are the first bills for more transparency for Medicare Dr. Nimgaonkar’s contributions Nimgaonkar at https://www.gastro. of the 116th Congress to pass that Advantage plans with prior autho- to the field of gastroenterology, org/news/physician-innovator- address the costs of drugs. rization so physicians are aware of and to advancing care for patients working-to-bring-new-tech-to-pa- The Administration finalizes rule what services require it. with chronic liver disease, began in tients-thanks-to-aga-funding. on drug costs in advertising. The Medical Nutrition Equity Act intro- his small lab at Johns Hopkins Uni- Trump administration finalized duced in House. Rep. Jim McGovern, versity, Baltimore. [email protected] a rule that would require drug D-Mass., introduced H.R. 2501, the When Dr. Nimgaonkar received manufacturers to disclose prices Medical Nutrition Equity Act, leg- his funding from the AGA Research Help AGA build a community of on their products in television ad- islation that would mandate cov- Foundation in 2014, he was able to investigators through the AGA vertisements. Manufacturers must erage of medically necessary foods focus on developing a technology Research Foundation. list a product’s monthly wholesale for individuals with digestive and that would enable patients with Your donation to the AGA price or the cost of a typical treat- inherited metabolic disorders. AGA refractory ascites to manage their Research Foundation can fund ment if it is greater than $35 for 30 is supportive of this legislation that condition at home. This is a condi- future success stories by keep- days. The information must appear is critical for patients with diges- tion in which a large volume of fluid ing young scientists working to in text large enough for people to tive diseases and ensures their ac- accumulates in the abdomen, caus- advance our understanding of read it and should also include a cess to these lifesaving products. es difficulty breathing, and affects digestive diseases. Donate today statement that people with insur- patients’ quality of life. Patients at www.gastro.org/donateonline. ance may pay a different amount [email protected] visit a hospital or clinic several Top AGA Community patient cases

hysicians with difficult patient scenarios due to pyogenic liver abscess, which had rup- Pregularly bring their questions to the AGA tured into the peritoneal cavity. Member seeks Community (https://community.gastro.org) to consult from the AGA Community on treatment seek advice from colleagues about therapy and options given this serious infection. A member asks if you would continue yearly CRC disease management options, best practices, and surveillance on a patient with Crohn’s colitis diagnoses. In case you missed it, here are the 2. EUS-guided cholecystoenterostomy with LAMS with very limited colonic involvement in the as- most popular clinical discussions shared in the (http://ow.ly/IqLP50uyXLg) cending colon, who is currently in clinical remis- forum recently: A member poses the question: How long should sion. The patient also has small duct PSC with the stent stay in? early cirrhosis. 1. Crohn’s disease, infliximab and liver abscess (http://ow.ly/mTod50uyXCQ) 3. Colorectal cancer surveillance in Crohn’s coli- Access these clinical cases and more discus- A 22-year-old Crohn’s patient presented to the tis and small duct PSC sions at https://community.gastro.org/discus- hospital in septic shock with acute renal failure (http://ow.ly/tbe650uyXQh) sions. MDEDGE.COM/GIHEPNEWS • JULY 2019 IBD AND INTESTINAL DISORDERS 15

an IBD Characteristics Assessment Checklist Pathway guides clinicians and referrals and a Referral Feedback form to accompany the IBD from page 1 pathway. The checklist is designed for use by any tive, and a patient advocacy representative. to outpatient IBD therapy, history of IBD-relat- health care professional to help identify wheth- The pathway identifies the top three areas ed surgery, and malnourishment. er a patient needs to be referred based on the where IBD patients usually present with symp- Moderate-risk characteristics include anemia key characteristics; the feedback form gives toms: the emergency department, primary care without clinical symptoms, chronic corticoste- gastroenterologists a template to communicate office, and gastroenterology office. roid use, and no emergency department or other with referring physicians about comanagement The work group developed a list of key char- GI medical visits within the past year. strategies for the patient. acteristics associated with increased morbidity, Low-risk characteristics include chronic The pathway also includes more details on established IBD, or IBD-related complications narcotic use, one or more comorbidities (such how clinicians can tackle barriers to mental that can be separated into high-risk, moderate- as heart failure, active hepatitis B, oncologic health and nutrition care for IBD patients. risk, and low-risk groups to help clinicians de- malignancy, lupus, GI infections, primary scle- “Until further evaluations are conducted, the termine the timing of and need for referrals. rosing cholangitis, viral hepatitis, and celiac work group encourages the immediate use of The pathway uses a sample patient present- disease), one or more relevant mental health the pathway to begin addressing the needed ing with GI symptoms such as bloody diarrhea; conditions (such as depression, anxiety, or improvements for IBD care coordination and GI bleeding; anemia; fecal urgency; fever; ab- chronic pain), and nonadherence to IBD medi- communication between the different IBD pro- dominal pain; weight loss; and pain, swelling, cal therapies. viders,” the authors wrote. or redness in the joints. Clinicians then apply “Referrals should be based on the highest lev- Dr. Kinnucan disclosed serving as a consul- the key characteristics to triage the patients el of risk present, in the event that a patient has tant for AbbVie, Janssen, and Pfizer and serving into the risk groups. characteristics that fall in more than one risk on the Patient Education Committee of the High-risk characteristics include history of category,” the work group wrote. Crohn’s and Colitis Foundation. perianal or severe rectal disease, or deep ulcers To further guide clinicians in referring pa- in the GI mucosa; two or more emergency de- tients with possible or diagnosed IBD to gastro- [email protected] partment visits for GI problems within the past enterology specialists and to mental health and SOURCE: Kinnucan J et al. Gastroenterology. 2019. doi: 6 months, severe anemia, inadequate response nutrition specialists, the work group developed 10.1053/j.gastro.2019.03.064.

Our top priority is ensuring patient New donor rules outlined safety from microbiome-based ther- Microbiota from page 1 apeutics, such as FMT. Through the AGA FMT National Registry, AGA is developed infections caused by ex- Examples of persons at higher risk working with physicians and pa- tended-spectrum beta-lactamase for colonization with MDROs in- tients to track FMT usage, patient (ESBL)–producing Escherichia coli. clude: outcomes and adverse events. Asso- One of the patients died. a. Health care workers ciated with the registry is a biore- “This is certainly a theoretical b. Persons who have recently pository of donor and patient stool risk that we’ve known about,” Lea been hospitalized or discharged samples, which will allow further Ann Chen, MD, a gastroenterologist from long-term care facilities investigation of unexpected events at New York University, said in an c. Persons who regularly attend such as those described in FDA’s interview. “This announcement is outpatient medical or surgical clinics safety alert.” important, because we probably d. Persons who have recently en- Dr. Chen, who received the AGA don’t counsel patients specifically gaged in medical tourism Research Foundation’s 2016 Re- about this risk. We say there is a risk 2. FMT donor stool testing must search Scholar Award for her work for transmission of infectious agents include MDRO testing to exclude on the gut microbiome and inflam- in general, but I think that probably use of stool that tests positive for Dr. Lea Ann Chen said it’s not that FMT is matory bowel disease, pointed out very few counsel patients about a MDRO. The MDRO tests should at ‘bad’; we just have to be more diligent about that FMT has also been studied as a risk for transmission of MDROs.” minimum include ESBL-producing optimizing the safety of the procedure. way to prevent colonization and in- The donor stool and FMT used Enterobacteriaceae, vancomycin-re- fection with certain drug-resistant in the two patients were not tested sistant enterococci (VRE), carbap- been tested and found negative. In organisms, such as VRE. for ESBL-producing gram-negative enem-resistant Enterobacteriaceae the case of FMT products manufac- “Therefore, it’s not that FMT is organisms prior to use. (CRE), and methicillin-resistant tured using pooled donations from ‘bad;’ we just have to be more dili- As a result of these serious ad- Staphylococcus aureus (MRSA). Cul- a single donor, stored samples of the gent about optimizing the safety of verse reactions, the FDA has deter- ture of nasal or perirectal swabs is individual donations prior to pooling the procedure by screening for of mined that certain donor screening an acceptable alternative to stool must be tested before the FMT prod- multidrug-resistant organisms,” she and stool testing protections are testing for MRSA only. Bookend ucts can be administered to subjects. said. “We also need to study the use needed for any investigational use testing (no more than 60 days 4. The informed consent process of FMT more, so that we can fully of FMT. On June 18, the agency apart) before and after multiple for subjects being treated with understand the risks associated released an additional statement, stool donations is acceptable if FMT product under your IND go- with the procedure. It’s an import- which stipulated that all Investi- stool samples are quarantined until ing forward should describe the ant and potentially lifesaving pro- gational New Drug (IND) holders the postdonation MDRO tests are risks of MDRO transmission and cedure for some, but it’s important must implement the following new confirmed negative. invasive infection as well as the that everyone go into the procedure requirements no later than July 15, 3. All FMT products currently in measures implemented for donor understanding fully what the risks 2019: storage for which the donor has not screening and stool testing. and benefits are.” 1. Donor screening must include undergone screening and stool test- On June 14, the American Gas- Suspected adverse events related questions that specifically address ing for MDROs as described above troenterological Association sent a to the administration of FMT prod- risk factors for colonization with must be placed in quarantine until communication about the FDA alert ucts can be reported to the FDA at MDROs, and individuals at higher such time as the donor is confirmed to its members, which stated that 1-800-332-1088 or via MedWatch. risk of colonization with MDROs to be not at increased risk of MDRO the AGA “is committed to advancing must be excluded from donation. carriage and the FMT products have applications of the gut microbiome. [email protected] GIHEP_18.indd 1 10/15/2018 12:34:22 PM MDEDGE.COM/GIHEPNEWS • JULY 2019 IBD AND INTESTINAL DISORDERS 19 FDA approves IB-Stim device Persistent fatigue plagues for abdominal pain in IBS many IBD patients

BY MARY JO M. DALES device and 23 patients received a BY DOUG BRUNK attainment of clinical remission and MDedge News placebo device. The study measured MDedge News the resolution of fatigue. change from baseline to the end of Of the 326 patients, 134 initiated REPORTING FROM DDW 2019 he IB-Stim device has been ap- the third week in worst abdominal biologic therapy with infliximab or proved to aid in the reduction pain, usual pain, and Pain Frequency SAN DIEGO – Nearly two-thirds of adalimumab, 129 with vedolizumab, Tof functional abdominal pain Severity Duration (PFSD) scores. patients with inflamma- and 63 with ustekinum- in patients 11-18 years of age with Patients were allowed to continue tory bowel disease who ab. Nearly two-thirds of irritable bowel syndrome (IBS), stable doses of medication to treat initiate biologic therapy patients (198, or 61%) re- according to the U.S. Food and Drug chronic abdominal pain. continue to experience ported significant fatigue Administration. IB-Stim treatment resulted in at persistent fatigue up to 1 at baseline, which was “This device offers a safe option least a 30% decrease in usual pain at year later, results from a associated with female for treatment of adolescents expe- the end of 3 weeks in 52% of treat- prospective cohort study sex, depressive symptoms, riencing pain from IBS through the ed patients, compared with 30% of presented at the annual and disturbed sleep (P use of mild nerve stimulation,” Car- patients who received the placebo, Digestive Disease Week® less than .001). Those re- los Peña, PhD, director of the Office and at least a 30% decrease in worst showed. porting significant fatigue of Neurological and Physical Medi- pain in 59% of treated patients, In an effort to define the DR. BORREN at baseline also had high- cine Devices in the FDA’s Center for compared with 26% of patients who trajectory of fatigue in IBD er disease activity scores, Devices and Radiological Health, received the placebo. patients initiating treatment with in- compared with those without fa- said in a press release. The treatment group also had fliximab, adalimumab, vedolizumab, tigue (P less than .001). The prescription-only device greater changes in composite PFSD or ustekinumab, lead study author Of the 198 patients who reported has a single-use electrical nerve scores at the end of 3 weeks. During Nynke Z. Borren, MD, and colleagues fatigue at baseline, 70% remained stimulator that is placed behind the study, six patients reported mild prospectively enrolled 206 patients fatigued at week 14, while 63% the patient’s ear. Stimulating nerve ear discomfort, and three patients with Crohn’s disease and 120 pa- remained fatigued at week 30, and bundles in and around the ear is reported adhesive allergy at the tients with ulcerative colitis. Dr. 61% remained fatigued at week 54. thought to provide pain relief. The site of application, according to the Borren is a research fellow at the The researchers observed no signif- battery-powered chip of the device press release. Massachusetts General Hospital icant differences between the ther- emits low-frequency electrical puls- The device is contraindicated for Crohn’s and Colitis Center, Boston. apies in the proportion of patients es continuously for 5 days, at which patients with hemophilia, patients They used the seven-point fatigue who remained fatigued. In addition time it is replaced. Patients can use with cardiac pacemakers, or those question in the Short Inflammatory to disease activity, disturbed sleep at the device for up to 3 consecutive diagnosed with psoriasis vulgaris. Bowel Disease Questionnaire to baseline was associated with fatigue weeks to reduce functional abdomi- The FDA granted marketing au- define fatigue; a score of four or at week 14 (odds ratio, 9.7) and at nal pain associated with IBS. thorization of the IB-Stim to Inno- less for this question equaled fa- week 30 (OR, 3.7). The FDA reviewed data from 50 vative Health Solutions. tigue. Next, they used multivariable The researchers had no conflicts. patients, aged 11-18 years, with IBS; regression models to examine the 27 patients were treated with the [email protected] independent association between [email protected] CLINICAL CHALLENGES AND IMAGES What’s your diagnosis? By Wai See Ma, MD, Hadi Moat- surgery to remove a cyst, and tar, MD, and Crispin Musumba, another had died of an unspec- MBChB, PhD. Published pre- ified brain tumor at 25 years viously in Gastroenterology of age. Her mother had died of (2018;154[4]:814-5). ovarian cancer. Physical examination was 32-year-old Filipino woman unremarkable, with a normal A was referred for endoscopic pulse rate and blood pressure ultrasound (EUS) imaging of and no anemia, jaundice, or the pancreas from another hos- lymphadenopathy. Laboratory pital where she had presented investigations including a full visualized on computed to- with a history of intermittent blood count, urea and electro- mography scan (Figure B). EUS abdominal pain with radiation lytes, liver function tests, thy- revealed multiple thinly septat- to the back precipitated by alco- roid function tests, and serum ed anechoic cysts throughout hol, and recurrent palpitations. lipase were all normal. Abdom- the pancreas, the largest During outpatient review before inal computed tomography and measuring 36 mm located in EUS, she gave a background ultrasound imaging revealed the body, with no associated history of previous laparoscopic multiple cysts of varying sizes masses (Figure C). ovarian cystectomy, as well as throughout the pancreas (Fig- What is the likely diagnosis? multiple previous admissions ure A), as well as multiple small What other investigations with supraventricular tachy- benign-looking cysts in the liver. would you do for confirma- cardia requiring cardioversion In addition, there was a 17-mm tion? tute on one occasion. One of her hyperdense solid lesion in the

brothers had undergone brain midpole of her right kidney The diagnosis is on page 28. I nst AGA 20 PANCREAS & BILIARY TRACT JULY 2019 • GI & HEPATOLOGY NEWS Asymptomatic gallstones seldom require surgery

BY DOUG BRUNK Dr. Morris­Stiff and his colleagues intervention: increasing age (hazard MDedge News constructed Kaplan­Meier curves ratio, 0.94; P less than 0.001), male sex (HR, 0.78; P less than 0.001), REPORTING FROM DDW 2019 to analyze time to intervention and calculated cumulative incidence ra­ and statin use (HR, 0.67; P less than SAN DIEGO – In patients with as­ tios. They used automated forward 0.001). ymptomatic gallstones, the need for stepwise competing risk regression Patient variables associated with surgical intervention increases over to create their model and receiver increased need for surgical inter­ time to 25%, according to results operating characteristics curves to vention included obesity (HR, 1.44; ews from a large, long­term analysis n analyze it. P less than 0.001) and having a presented at the annual Digestive ge Of the 49,414 patients identi­ hemolytic disorder (HR, 2.42; P less Disease Week®. fied with asymptomatic gallstones, than 0.001). Gallstone-specific char­

Lead study author Gareth Morris­ runk /MD e D 22,257 met criteria for analysis. acteristics that increased the need for Stiff, MD, PhD, of the department of About half (51%) were female, their surgical intervention included a stone oug B general surgery at Cleveland Clinic, D mean age was 61 years, 80% were size greater than 9 mm (HR, 1.56; said that, while previous studies have Dr. Gareth Morris-Stiff and coworkers white, 16% were black, and the rest P less than 0.001), the presence of evaluated the time to development of developed a web-based risk score. were from other racial/ethnic groups. sludge (HR, 1.46; P less than 0.001), gallstone­related complications fol­ The median follow­up was 4.5 years; the presence of a polyp (HR, 1.68; P lowing identification of asymptomatic The researchers included Cleve­ for those undergoing intervention, less than 0.001), and multiple stones gallstones, factors associated with the land Clinic patients with CT/US re­ 3.9 years. This translated to 112,111 (HR, 1.69; P less than 0.001). need for surgical intervention in this ports containing “cholelithiasis” or total years of observation. Dr. Morris­Stiff and colleagues population have not been document­ “gallstones” between January 1996 The researchers found that the generated a web­based risk score to ed. The current study aimed to per­ and December 2016. Patients were cumulative incidence of intervention reliably identify these patients and form a big data analysis to evaluate excluded if they had a concurrent at 15 years was 25% and it increased provide prognostic information for risk factors associated with interven­ or prior event, had an event within linearly from the time of initial diag­ counseling. A smartphone app based tion in asymptomatic gallstones and 2 months, or lacked follow­up. Data nosis of gallstones. A total of 1,762 on the score is being developed. The to develop a risk stratification tool collection included demographic patients (7.9%) underwent a surgical researchers reported having no fi­ to aid in predicting when individuals characteristics, comorbid condi­ procedure, most often cholecystecto­ nancial disclosures. were likely to need future interven­ tions or surgeries, imaging features, my (5.7%). Three factors were asso­ tion for their gallstones. and medication use. ciated with reduced risk for surgical [email protected] Early cholecystectomy prevents recurrent biliary events

BY KARI OAKES sures: cholecystectomy rates performed during tween 30 and 60 days after hospitalization. Just MDedge News an index hospitalization for gallstone pancreati­ 12 patients (16%) of this subgroup had their cho­ tis and recurrent biliary events after hospitaliza­ lecystectomy within 30 days of hospitalization. REPORTING FROM DDW 2019 tion. Adult patients were included if they had a Among patients who were discharged without SAN DIEGO – Waiting to perform cholecystecto­ diagnosis of acute gallstone pancreatitis, with or a cholecystectomy, Dr. Dalapathi and his coau­ my after mild biliary pancreatitis was associated without recurrent cholangitis, choledocholithia­ thors found 26 recurrent biliary events (19%): with an increased risk of recurrent biliary events sis, or acute cholecystitis. Pediatric patients and 15 were gallstone pancreatitis, and 10 were cho­ in a recent study. In a retrospective study of 234 those with prior cholecystectomy were excluded. lecystitis; 1 patient developed cholangitis. patients admitted for gallstone pancreatitis, al­ A total of 234 patients were included in the The crux of the study’s findings came when the most 90% of recurrent biliary events occurred in study. Their mean age was 58.3 years, and pa­ investigators looked at the association between patients who did not receive a cholecystectomy tients were mostly female (57.3%) and white recurrent events and cholecystectomy timing. within 60 days of hospital discharge. The overall (91.5%). Mean body mass index was 29.1 kg/m2. They found no recurrent biliary events among rate of recurrence was 19%, and over half of pa­ A total of 175 patients (74.8%) had endoscopic those who received cholecystectomy while hospi­ tients (59%) did not receive a cholecystectomy retrograde cholangiopancreatography. talized or within the first 30 days after discharge. during their index hospitalization. Of the entire cohort of patients, 138 (59%) Of the 26 events, 3 (12%) occurred in those Additionally, none of the recurrent biliary did not have a cholecystectomy during the index whose cholecystectomies came 30­60 days after events occurred in those patients who did hospitalization. Among the patients who did discharge. The remaining 23 events (88%) were receive a cholecystectomy during the index not receive a cholecystectomy, 33 (24%) were seen in those receiving a cholecystectomy more hospitalization or within the first 30 days af­ deemed unsuitable candidates for the procedure, than 60 days after discharge, or not at all. ter discharge. “It really is the case that, ‘if you either because they were critically ill or because Guidelines from the American Gastroenter­ snooze, you lose,’ ” said Vijay Dalapathi, MD, pre­ they were poor candidates for surgery for other ological Association, the Society of American senting the findings during an oral presentation reasons. No reason was provided for the nonper­ Gastrointestinal and Endoscopic Surgeons, and at the annual Digestive Disease Week®. formance of cholecystectomy for an additional 28 the American College of Gastroenterology rec­ Dr. Dalapathi and colleagues had observed that patients (20%). ommend early cholecystectomy after mild acute cholecystectomy during an index hospitalization The remaining 75 patients (54%) were de­ gallstone pancreatitis, said Dr. Dalapathi. for mild biliary pancreatitis was a far from uni­ ferred to outpatient management. Looking at “Cholecystectomy should be performed during versal practice. To delve further into practice this subgroup of patients, Dr. Dalapathi and his index hospitalization or as soon as possible within patterns, Dr. Dalapathi, first author Mohammed coinvestigators tracked the amount of time that 30 days of mild biliary pancreatitis to minimize Ullah, MD, and their coauthors at the University passed before cholecystectomy. risk of recurrent biliary events,” said Dr. Dalapathi. of Rochester (N.Y.) conducted a single­site ret­ The researchers found that 19 patients (25%) The authors reported no outside sources of rospective study of patients who were admitted had not had a cholecystectomy within the study funding and no conflicts of interest. with gallstone pancreatitis over a 5­year period period. A total of 21 patients (28%) had the pro­ ending December 2017. cedure more than 60 days from hospitalization, [email protected] The study had twin primary outcome mea­ and another 23 (31%) had the procedure be­ SOURCE: Ullah M et al. DDW 2019, Abstract 24. * Use as directed. Take 1 pill in the morning for 14 days. May take ‡Complete resolution of heartburn was defi ned as 7 consecutive 1 to 4 days for full e† ect. days without heartburn. † Based on a post hoc analysis of 2-week data from 2 previously § First resolution defi ned as a study day when patients recorded published identical phase IV, multicenter, randomized, double- “NO” sleep disturbances due to frequent heartburn on daily blind, placebo-controlled trials that demonstrated effi cacy diary card. and safety of esomeprazole 20 mg once daily in the morning in subjects with sleep disturbances due to refl ux and frequent nighttime heartburn.

References: 1. National Sleep Foundation. Ease heartburn at bedtime. https://sleep.org/articles/ease-heartburn-bedtime/. Accessed August 6, 2018. 2. Johnson DA, Le Moigne A, Hugo V, Nagy P. Rapid resolution of sleep disturbances related to frequent refl ux: e† ect of esomeprazole 20 mg in two randomized, double-blind, controlled trials. Curr Med Res Opin. 2015;31(2):243-250.

©2018 Pfi zer Inc. PP-NEX-USA-1961 09/18

GIHEP_21.indd 1 5/21/2019 9:34:53 AM 22 LIVER DISEASE JULY 2019 • GI & HEPATOLOGY NEWS AGA CLINICAL PRACTICE UPDATE Management of coagulation in cirrhosis

BY AMY KARON ometry, and thrombin generation may eventually thrombosis, presence or absence of attributable MDedge News have a role in the evaluation of clotting in patients symptoms, and the risk of bleeding and falls,” the with cirrhosis but currently lack validated target experts stated. irrhosis can involve “precarious” changes levels,” the experts wrote. Six-month follow-up imaging is recommended in hemostatic pathways that tip the scales They advised clinicians to limit the use of blood to assess anticoagulation efficacy. More frequent Ctoward either bleeding or hypercoagulation, products (such as fresh frozen plasma and pooled imaging can be considered for PVT patients con- experts wrote in an American Gastroenterological platelet transfusions) because of cost and the risk sidered at high risk for therapeutic anticoagula- Association Clinical Practice Update. of exacerbated portal hypertension, infection, and tion. If clots do not fully resolve after 6 months of Based on current evidence, clinicians should immunologic complications. For severe anemia treatment, options including extending therapy not routinely correct thrombocytopenia and co- and uremia, red blood cell transfusion (250 mL) with the same agent, switching to a different agulopathy in patients with cirrhosis prior to low- can be considered. Platelet-rich plasma from one anticoagulant class, or receiving transjugular risk procedures, such as therapeutic paracentesis, donor is less immunologically risky than a pooled intrahepatic portosystemic shunt (TIPS). “The thoracentesis, and routine upper endoscopy for platelet transfusion. Thrombopoietin agonists are role for TIPS in PVT is evolving and may address variceal ligation, Jacqueline G. O’Leary, MD, AGAF, “a good alternative” to platelet transfusion but re- complications like portal hypertensive bleeding, of Dallas VA Medical Center and her three corev- quire about 10 days for response. Alternative pro- medically refractory clot, and the need for repeat- iewers wrote in Gastroenterology. thrombotic therapies include oral thrombopoietin ed banding after variceal bleeding,” the experts For optimal clot formation prior to high-risk receptor agonists (avatrombopag and lusutrom- noted. procedures, and in patients with active bleeding, bopag) to boost platelet count before an invasive Prophylaxis of DVT is recommended for all a platelet count above 50,000 per mcL is still rec- procedure, antifibrinolytic therapy (aminocaproic hospitalized patients with cirrhosis. Vitamin K ommended. However, it may be more meaningful acid and tranexamic acid) for persistent bleeding antagonists and direct-acting oral anticoagulants to couple that platelet target with a fibrinogen from mucosal oozing or puncture wounds. Des- (dabigatran, apixaban, rivaroxaban, and edox- level above 120 mg/dL rather than rely on the mopressin should be considered only for patients aban) are alternatives to heparin for anticoagu- international normalized ratio (INR), the experts with comorbid renal failure. lation of cirrhotic patients with either PVT and wrote. Not only does INR vary significantly de- For anticoagulation, the practice update recom- DVT, the experts wrote. However, DOACs are not pending on which thromboplastin is used in the mends considering systemic heparin infusion for recommended for most Child-Pugh B patients or test, but “correcting” INR with a fresh frozen plas- cirrhotic patients with symptomatic deep venous for any Child-Pugh C patients. ma infusion does not affect thrombin production thrombosis (DVT) or portal vein thrombosis (PVT). No funding sources or conflicts of interest and worsens portal hypertension. Using cryopre- However, the anti–factor Xa assay will not reliably were reported. cipitate to replenish fibrinogen has less impact monitor response if patients have low liver-de- on portal hypertension. “Global tests of clot for- rived antithrombin III (heparin cofactor). “With [email protected] mation, such as rotational thromboelastometry newly diagnosed PVT, the decision to intervene SOURCE: O’Leary JG et al. Gastroenterology. 2019. doi: (ROTEM), thromboelastography (TEG), sonorhe- with directed therapy rests on the extent of the 10.1053/j.gastro.2019.03.070. Early TIPS shows superiority to standard care for advanced cirrhosis with acute variceal bleeding

BY WILL PASS such patients, [TIPS] is successful To this end, the investigators variceal eradication, and addition- MDedge News in achieving hemostasis in 90%- screened 373 patients with ad- ally if varices reappeared. TIPS 100% of patients. However, 6-week vanced cirrhosis (Child-Pugh class was allowed as rescue therapy. or patients with advanced mortality remains high [35%- B or C) and acute variceal bleed- In contrast, patients in the TIPS Fcirrhosis and acute variceal 55%]. This is probably because ing. Of these, 132 were eligible for group underwent the procedure bleeding, early treatment with the severity of the underlying liver inclusion based on age, disease with conscious sedation and local transjugular intrahepatic porto- disease has worsened and addi- severity, willingness to participate, anesthesia within 72 hours of diag- systemic shunt (TIPS) appears to tional organ dysfunction may have comorbidities, and other factors. nostic endoscopy, followed by ap- improve transplantation-free sur- occurred after several failed endo- Patients were randomized 2:1 to proximately 1 week of antibiotics vival, according to investigators. scopic therapy attempts.” receive either early TIPS or stan- and vasoactive drugs. TIPS revision Early TIPS “should therefore be Previous studies have explored dard therapy. with angioplasty or another stent preferred to the current standard earlier intervention with TIPS; Within 12 hours of hospital placement was performed in the of care,” reported lead author Yong however, according to the inves- admission for the initial bleed- event of shunt dysfunction or re- Lv, MD, of the Fourth Military Med- tigators, these trials were incon- ing episode, all patients received emergence of portal hypertensive ical University in Xi’an, China, and clusive for various reasons. For vasoactive drugs or endoscopic complications. The final dataset colleagues, referring to standard example, uncovered stents and an band ligation and prophylactic contained 127 patients, as 3 were pharmaceutical and endoscopic out-of-date control therapy were antibiotics. Control patients con- excluded after randomization be- therapy. employed in a trial by Monescillo tinued vasoactive drugs for up to cause of exclusionary diagnoses, 1 “[The current standard] ap- et al., while a study by Garcia-Pa- 5 days, followed by propranolol, withdrew consent, and 1 died be- proach has improved patient out- gan et al. lacked a primary survival which was titrated to reduce rest- fore TIPS placement. comes,” the investigators wrote endpoint and has been criticized ing heart rate by 25% but not less The primary endpoint was in the Lancet Gastroenterology for selection bias. “Thus, whether than 55 beats per minute. Elective transplantation-free survival. The & Hepatology. “However, up to early TIPS confers a survival bene- endoscopic band ligation was secondary endpoints were new or 10%-20% of patients still experi- fit in a broader population remains performed within 1-2 weeks of worsening ascites based on ultra- ence treatment failure, requiring to be assessed,” the investigators initial endoscopic treatment, then sound score or sustained ascites further intensive management. In wrote. approximately every 2 weeks until Continued on following page MDEDGE.COM/GIHEPNEWS • JULY 2019 LIVER DISEASE 23

Continued from previous page hepatic encephalopathy and other “Future studies addressing of Shaanxi Province, and National adverse events,” the investigators whether early TIPS can be equally Natural Science Foundation of Chi- necessitating paracentesis, failure concluded. “This study provides recommended in Child-Pugh B and na. The investigators reported no to control bleeding or rebleeding, direct evidence and greater confi- C patients are warranted,” the in- conflicts of interest. overt hepatic encephalopathy, oth- dence in the recommendations of vestigators added. er complications of portal hyper- current guidelines that early TIPS The study was funded by the [email protected] tension, and adverse events. should be performed in high-risk National Key Technology R&D SOURCE: Lv Y et al. Lancet Gastroenterol After a median follow-up of 24 patients without contraindica- Program, Boost Program of Xijing Hepatol. 2019 May 29. doi: 10.1016/ months, data analysis showed a tions. Hospital, Optimized Overall Project S2468-1253(19)30090-1. survival benefit associated with early TIPS based on multiple mea- sures. Out of 84 patients in the TIPS group, 15 (18%) died during follow-up, compared with 15 (33%) in the control group. Actu- arial transplantation-free survival was also better with TIPS instead of standard therapy at 6 weeks (99% vs. 84%), 1 year (86% vs. 73%), and 2 years (79% vs. 64%). ® The hazard ratio for transplanta- CROHN’S & COLITIS CONGRESS tion-free survival was 0.50 in favor of TIPS (P = .04). These survival JANUARY 23–25, 2020 | Austin, TX advantages were maintained re- gardless of hepatitis B virus status or Child-Pugh/Model for End-Stage Liver Disease score. Similarly to transplantation-free survival, patients treated with TIPS TRANSFORMING IBD CARE were more likely to be free of un- controlled bleeding or rebleeding at 1 year (89% vs. 66%) and 2 years (86% vs. 57%). The associ- ated hazard ratio for this outcome favored early TIPS (HR, 0.26; P less than .0001), and univariate and multivariate analysis confirmed an independent protective role. In further support of superiority over standard therapy, patients treated with TIPS were more likely than those in the control group to be free of new or worsening ascites at 1 year (89% vs. 57%) and 2 years (81% vs. 54%). No significant intergroup dif- ferences were found for rates of GET INSPIRED TO TRANSFORM IBD CARE overt hepatic encephalopathy, The premier conference for inflammatory bowel disease hepatic hydrothorax, hepatorenal (IBD) professionals is headed to Austin, Texas. syndrome, spontaneous bacterial peritonitis, hepatocellular carci- Connect with fellow IBD leaders, learn more about noma, serious adverse events, or the latest research, and hear what’s on the horizon nonserious adverse events. At 1 in potential treatments. Leave with practical and 3 months, patients in the TIPS information you can immediately implement. group had a slight increase of me- dian bilirubin concentrations and Register by September 18 median international normalized ratio; however, these values nor- and save up to $200. malized after 6 months. A similar temporal pattern was observed in Abstract submissions open late August. early TIPS patients with regard to Exhibit Hall: January 24 & 25, 2020 median Model for End-Stage Liver Disease score. “[The transplantation-free sur- To learn more and register, visit vival benefit of early TIPS] was probably related to better control www.crohnscolitiscongress.org of factors contributing to death, such as failure to control bleeding or rebleeding or new or worsen- ing ascites, without increasing the frequency and severity of overt 24 UPPER GI TRACT JULY 2019 • GI & HEPATOLOGY NEWS Meta-analysis finds no link between PPIs and dementia

BY DOUG BRUNK studies, including a large pharma- really give you a good causality ba- MDedge News coepidemiological claims data anal- sis,” lead study author Saad Alrajhi, Key clinical point: ysis from Germany, that propose an MD, said in an interview at the annu- The incidence of dementia was REPORTING FROM DDW 2019 association between proton pump al Digestive Disease Week®. not significantly increased among SAN DIEGO – There is no signif- inhibitor (PPI) use and the devel- In an effort to better characterize patients in the PPI-exposed icant increased risk of dementia opment of dementia (JAMA Neurol. the association between PPI expo- group (OR, 1.08; 95% CI, 0.97-1.20; among patients who use proton 2016;73[4]:410-6). “The issue with sure and dementia, Dr. Alrajhi, a P = .18). pump inhibitors, compared with these studies is that they’re based gastroenterology fellow at McGill those who don’t, results from a sys- on retrospective claims data and University, Montreal, and colleagues tematic meta-analysis suggest. pharmacoepidemiological studies conducted a meta-analysis of all fully or observational studies compar- The finding runs counter to recent and insurance databases that don’t published randomized clinical trials ing use of PPIs and occurrence of dementia. The researchers queried Embase, MEDLINE, and ISI Web of Knowledge for relevant studies that were published from 1995 through September 2018. Next, they as- sessed the quality of the studies by using the Cochrane risk assessment Finding the right

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COM19-024 ou G D Dr. Saad Alrajhi said the databases on which the recent studies are based are not a good basis for causality.

tool for RCTs or the Newcastle-Otta- wa Scale for observational studies. 2019 AGA Postgraduate As the primary outcome, the researchers compared dementia Course Resources incidence after PPI exposure (ex- perimental group) versus no PPI exposure (control group). Develop- Knowledge Gained. Knowledge Shared. ment of Alzheimer’s dementia was a secondary outcome. Sensitivity Resources include: USB session capture | Online session capture analyses consisted of excluding one USB and online sessions combo | eSyllabus | Printed abstract book study at a time, and assessing results among studies of highest qualities. Subgroup analyses included stratify- The 2019 postgraduate course Gain exposure to current updates ing patients by age. To report odds resources give you the power to access on a variety of disease states while ratios, Dr. Alrajhi and colleagues used fixed or random effects models a multi-topic course from your home, drawing on real clinical cases. based on the absence or presence of heterogeneity. office or while on the go. Covering the Visit AGA University at agau.gastro. Of 549 studies assessed, 5 met the most recent clinical advances, the 2019 org to purchase your resources today. criteria for inclusion in the final anal- ysis: 3 case-control studies and 2 co- resources provide knowledge that will hort studies, with a total of 472,933 patients. All of the studies scored 8 impact how you deliver patient care. or 9 on the Newcastle-Ottawa scale,

EDU19-56 indicating high quality. Significant Continued on following page MDEDGE.COM/GIHEPNEWS • JULY 2019 UPPER GI TRACT 25 Coffee, tea, and soda all up GERD risk

BY KARI OAKES A substitution analysis answered MDedge News the question of the effect of substi- tuting two glasses of plain water REPORTING FROM DDW 2019 daily for either coffee, tea, or soda. Dr. SAN DIEGO – Coffee, tea, and soda Mehta and colleagues saw a modest consumption are all associated with reduction in risk for GERD with this increased risk for gastroesophageal strategy. reflux disease (GERD), according to In addition to the prospective na- a new prospective cohort study pre- ture of the study (Abstract 514. doi: sented at the annual Digestive Dis- 10.1016/S0016-5085[19]37044-1), ease Week®. the large sample size, high follow-up In an interview, Raaj S. Mehta, MD, rates, and well validated dietary data said that patients in his primary were all strengths, said Dr. Mehta. ews

care panel at Massachusetts General n However, the study’s population is Hospital, Boston, where he’s a senior relatively homogeneous, and residual

resident, frequently came to him with MD eDG e confounding couldn’t be excluded. GERD. Patients frequently wanted to Whether the beverages were caffeinated or not, said Dr. Raaj S. Mehta, made only a Also, GERD was defined by self-re- know which beverages might pro- “minimal difference” in GERD risk. port, though participants were asked voke or exacerbate their GERD. to respond to clear, validated criteria. In trying to help his patients, Dr. increase as you go from one cup, to answered questions about GERD. Dr. Mehta reported no conflicts of Mehta said he realized that there two, to three, and so on, all the way Medication use, including the inci- interest. wasn’t a prospective evidence base up to six cups” of the offending bev- dent use of proton pump inhibitors, Digestive Disease Week is jointly about beverages and GERD, so he erages, said Dr. Mehta. was collected every 2 years. Patients sponsored by the American Associ- and his colleagues used data from Overall, the risk for GERD rose with baseline GERD or use of PPIs or ation for the Study of Liver Diseases the Nurses’ Health Study II (NHS II), from 1.17 to 1.34 with coffee con- H2 receptor antagonists were exclud- (AASLD), the American Gastroenter- a prospective cohort study, to look at sumption as servings per day in- ed from participation. ological Association (AGA) Institute, the association between various bev- creased from less than one to six or The quantity and type of beverag- the American Society for Gastroin- erages and the incidence of GERD. more (P for trend less than .0001). es were assessed by food frequency testinal Endoscopy (ASGE), and the “What’s exciting is that we were Tea consumption was associated questionnaires; other demographic, Society for Surgery of the Alimentary able to find that coffee, tea, and soda with increased GERD risk ranging dietary, and medication variables Tract (SSAT). – all three – increase your risk for from 1.08 to 1.26 as consumption were also gathered and used to ad- [GERD],” Dr. Mehta said in a video in- rose (P for trend .001). For soda, the just the statistical analysis. [email protected] terview. “At the highest quintile level, increased risk went from 1.12 at less so looking at people who consume than one serving daily, to 1.41 at four six or more cups per day, you’re look- to five servings daily, and then fell to ing at maybe a 25%-35% increase in 1.29 at six or more daily servings (P risk of reflux disease.” for trend less than .0001). There was a dose-response rela- Whether the beverages were caf- tionship as well: “You do see a slight feinated or not, said Dr. Mehta, made only a “minimal difference” in GERD IBD risk. “In contrast, we didn’t see an AGA Resource association for beverages like water, pancreatic disease Encourage your patients to juice, and milk,” he said – reassuring Learn what you want visit the AGA GI Patient Center findings in light of fruit juice’s anec- for education by specialists for dotal status as a GERD culprit. nutrition patients about GERD symptoms The NHS II collected data every esophageal disorders and treatments at https://www. 2 years from 48,308 female nurses gastro.org/practice-guidance/ aged 42-62 years at the beginning small bowel disease gi-patient-center/topic/gastro- of the study. Every 4 years dietary esophageal-reflux-disease-gerd. information was collected, and on the opposite 4-year cycle, participants DDSEP Continued from previous page exposure was not associated with the Digestive Diseases Self-Education Program development of Alzheimer’s demen- heterogeneity was noted for all anal- tia (two studies) (OR, 1.32; 95% CI, Customized by you yses. The researchers found that the 0.80-2.17; P = .27). incidence of dementia was not sig- “In the absence of randomized Whether preparing for a GI board exam or keeping nificantly increased among patients trial evidence, a PPI prescribing ap- in the PPI-exposed group (odd ratio, proach based on appropriate utiliza- current on advances in the field, DDSEP 9 allows you 1.08; 95% confidence interval, 0.97- tion of guideline-based prescription to customize learning where you want, what you want 1.20; P = .18). Sensitivity analyses should be done without the extra confirmed the robustness of the re- fear of the association of dementia,” and how you want. sults. Subgroup analysis showed no Dr. Alrajhi said. All at your fingertips. Also available on AGA University between-group differences among The researchers reported having studies that included a minimum age no financial disclosures. and ddsep.gastro.org above 65 years (three studies) or EDU19-45 less than age 65 (two studies). PPI [email protected] 26 ENDOSCOPY JULY 2019 • GI & HEPATOLOGY NEWS Artificial intelligence advances optical biopsy

BY KARI OAKES predictive value of 93.6%, Dr. MDedge News Byrne said. REPORTING FROM DDW 2019 The speed of the system’s deci- sion making is rapid, with a typical Research Funding SAN DIEGO – Artificial intelligence reaction time of 360 milliseconds. is improving the accuracy of op- The system was able to make di- tical biopsies, a development that agnostic inferences at a rate of 26 Opportunities may ultimately void the need for milliseconds per frame. tissue biopsies of many low-risk With exposure to more learning colonic polyps, Michael Byrne, MD, experiences, the artificial intelli- said at the annual Digestive Dis- gence system improved and com- ® The AGA Research Foundation is excited to ease Week . mitted to a prediction for 97.6% Dr. Byrne, chief executive officer of the polyps it visualized. Dr. announce the start of its 2020 research awards of Satisfai Health; Nicolas Guizard, Byrne said this result represented a gastroenterologist at Vancouver a 12.8% improvement from previ- cycle. This year the foundation will award over $2 General Hospital; and their col- ously published data on the model’s million in research funding to support researchers leagues have developed a “full clin- performance. ical workflow” for detecting colonic Dr. Byrne and his colleagues in gastroenterology and hepatology. The first two polyps and performing optical biop- found the system had a tracking grants open for applications focus on digestive sies of the polyps. accuracy of 92.8%, meaning that Using narrow band imaging this percentage of polyps was both cancers and are due on Aug. 7, 2019. (NBI) enhanced with artificial in- correctly detected and assigned to telligence, the system was used to a unique identifier for follow-up of review 21,804 colonoscopy frames the site of each excised polyp over AGA-R. Robert & Sally Funderburg Research and it achieved a “near-perfect” time. The interface worked even diagnostic accuracy of 99.9%. In an when multiple polyps were seen Award in Gastric Cancer assessment of colonoscopy videos on the same screen. that included 125 polyps, the sys- In a video interview, Dr. Byrne Designed for established investigators, this award tem had 95.9% sensitivity, with a discussed the implications for specificity of 91.6% and a negative Continued on following page provides $50,000 per year for two years (totaling $100,000) to work on novel approaches in gastric cancer research. Quick quiz answers AGA-Caroline Craig Augustyn & Damian Augustyn Award in Digestive Cancer Q1. Correct answer: D and prognosis prior to commit- ting to a G tube (answer E). This grant awards $40,000 for one year to an early Rationale Achalasia and pseudoachalasia Reference career investigator who currently holds a federal or are on the differential. Given the Zaninotto G, Bennett C, Boeckx- advanced age, progressive course, staens G, et al. The 2018 ISDE non-federal career development award devoted to and significant weight loss, an en- achalasia guidelines. Dis Esopha- conducting research related to digestive cancer. doscopy with careful attention to gus. 2018 Sep 1;31(9). GEJ should be performed to rule Other grants in the 2019-2020 season include: out malignancy causing a pseu- Q2. Correct answer: C doachalasia presentation (answer •AGA Research Scholar Awards D). Manometry should be done af- Rationale ter the endoscopy to confirm and Oral iron, and not infusions, are •AGA-Takeda Pharmaceuticals Research Scholar subtype the achalasia. If achalasia associated with peptic ulcer is confirmed and malignancy is disease. Sumatriptan alone, or Award in IBD ruled out, myotomy either with a tamoxifen, are not known to modified Heller approach or per- cause ulcers. •AGA-Gastric Cancer Foundation Ben Feinstein oral endoscopic myotomy would Memorial Research Scholar Award in Gastric Cancer be appropriate in a surgically fit Reference patient (answer A) and botulinum Miyake K, Kusunoki M, Shinji Y, toxin may be considered in a poor et al. Bisphosphonate increases surgical candidate. Medications risk of gastroduodenal ulcer in Learn more at gastro.org/research-funding. such as calcium channel blockers rheumatoid arthritis patients on and nitrates (answer C) are not long-term nonsteroidal anti-in- definitive treatment options for flammatory drug therapy. J Gas- achalasia and not warranted in troenterol. 2009;44(2):113. RSH19-16 malignancy. Additional informa- tion is needed on the diagnosis [email protected] MDEDGE.COM/GIHEPNEWS • JULY 2019 ENDOSCOPY 27 FDA clears modified endoscope connector

BY LUCAS FRANKI ness of the device at reducing the ERBEFLO 24-hour use port con- MDedge News risk of backflow and contamina- nector provides another option for AGA Resource tion is also supported by health care facilities whose The AGA Center for GI Innova- he Food and Drug Adminis- simulated testing. staff understand and can tion and Technology (https:// tration has announced the Revised labeling in- fully implement the instruc- www.gastro.org/aga-leadership/ Tclearance of a modified multi- cluded with the product tions for use to reduce the centers/aga-center-for-gi-innova- patient-use endoscope connector, identifies compatible risk of cross-contamination tion-and-technology) will continue which was designed to reduce the endoscopes and acces- and infection,” the FDA said to monitor this issue and encour- risk of cross-contamination previ- sories and provides warnings to in the May 23 update letter. ages all GIs to follow the most up- ously identified by the FDA. ensure proper usage. to-date FDA guidance. In a letter published April 18, the “The clearance of the modified [email protected] FDA had written that the original version of the product, the Erbe USA ERBEFLO port connector, was the

The FDA approval of the modified ERBEFLO port connector is based on a review of the functional and simulated use testing of Recognizing the modified device design. Distinction only one of its type on the market that did not feature a method of backflow prevention, as recom- Join the AGA Fellowship mended by new FDA guidelines. As Accepting applications such, the original ERBEFLO device did not adequately reduce the risk of through Aug. 26, 2019 cross-contamination; blood, stool, or This prestigious designation is awarded to select other fluids from previous patients could travel through the endoscopy members for their outstanding contributions to the channels, contaminating the connec- field of gastroenterology. Receive recognition for your tor, tubing, and water bottle. superior achievements and submit your application for The FDA approval of the modified AGA Fellowship today. ERBEFLO port connector is based Visit www.gastro.org/AGAF to learn more and apply. on a review of the functional and MEM19-9 simulated use testing of the mod- ified device design. The effective-

Continued from previous page gastroenterology and plans for a clinical trial for rigorous testing of the model. Join GI trailblazers and Satisfai Health is developing the leaders from AGA and DHPA AI colonoscopy technology. Dr. Byrne is a cofounder of ai4gi, which AGA Partners to network and discuss holds a technology codevelopment advanced strategies that agreement with Olympus US. will help you succeed in the

2019 changing business of health [email protected] in Value care. Leave equipped to OCT. 4, 2019 make better decisions for CHICAGO, ILLINOIS the future of your practice.

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PNQ19-9 28 PRACTICE MANAGEMENT JULY 2019 • GI & HEPATOLOGY NEWS The problem’s costs are real Annual cost of burnout per employed physician, 2015 Burnout from page 1 $12,000 Age <55 years on two productivity metrics related tends beyond physicians to nurses $10,000 Age ≥55 years to burnout – cost associated with and other health care staff. Future physician replacement and lost work holistically investigating the $8,000 income from unfilled physician po- costs associated with burnout in sitions. “Estimated turnover costs health care organizations would $6,000 were generally higher than costs of be valuable. Studies focusing on reduced productivity across all” the differences in burnout-attributable $4,000 various segments of age and special- costs across provider segments

ty, Ms. Han and associates wrote. other than the ones investigated ews $2,000 n

“Burnout is a problem that ex- in this study, including academic ge versus private settings, or across eD 0 mD a finer segmentation of physician Primary care physicians Surgical specialists Other specialists AGA Resource specialties also might be fruitful,” Learn practical tips to avoid phy- they wrote. Note: The cost-consequence analysis used a mathematical model incorporating such inputs as sician burnout presented during One investigator has received grants burnout prevalence, turnover, replacement cost, and reduction in clinical hours. an AGA symposium at DDW® from the American Medical Associa- Source: Ann Intern Med. 2019 May 28. doi: 10.7326/M18-1422 at https://www.ddwnews.org/ tion Accelerating Change in Medical news/aga-symposium-provides- Education Consortium, the Physi- University of Singapore. Ms. Han said practical-tips-to-avoid-physician- cians Foundation, and the National that she had no financial conflicts to [email protected] burnout/. Institutes of Health. Another received disclose. All of the investigators’ dis- SOURCE: Han S et al. Ann Intern Med. a startup grant from the National closures are available online. 2019 May 28. doi: 10.7326/M18-1422. CMS seeks answers on prior authorization, other hassles to docs

BY GREGORY TWACHTMAN Patients Over Paperwork initiative, seeks sugges- issue given the huge burden that prior autho- MDedge News tions on how to reduce hassles associated with rization plays in practices and the time that reporting and documentation, coding, prior autho- it takes away from providing care to patients. ot an idea on how to reduce administrative rization, rural issues, dual eligible patients, enroll- In the meantime, ask your legislator to sup- Gburden to help reduce the cost of delivering ment/eligibility determination and the agency’s port Improving Seniors Access to Timely Care health care? The Centers for Medicare & Medic- own process for issuing regulations and policies. Act of 2019, which was recently introduced in aid Services wants to hear from you. CMS Administrator Seema Verma said in a Congress to streamline the prior authorization In a request for information published June statement. “Our goal is to ensure that doctors are process in the Medicare Advantage program to 6, the agency seeks parties across the health spending more time with their patients and less relieve the administrative burdens this poses for care spectrum “to recommend further changes time in administrative tasks.” physicians and help patients receive quicker ac- to rules, policies, and procedures that would The request for information was published in cess to the medical care they need. Learn more shift more of clinicians’ time and our health care the Federal Register on June 11. Comments are at http://ow.ly/tJfX30oW5l7. system’s resources from needless paperwork to due to the agency by Aug. 12. Comments can be high-quality care that improves patient health,” made at www.regulations.gov and should refer [email protected] CMS officials said in a statement. to file code CMS-6082-NC. SOURCE: Federal Register, CMS-6082-NC, https://federal- The request for information, part of the agency’s AGA will submit comments to CMS on this register.gov/d/2019-12215. CLINICAL CHALLENGES AND IMAGES tions of the VHL tumor suppressor cysts (91%), microcystic serous cys- cause EUS is now widely used for The diagnosis gene, with an incidence of 1 in tadenomas (12%), solid pancreatic the evaluation of pancreatic cysts, 36,000 live births. The commonest neuroendocrine tumors (5%-10%), gastroenterologists may be first Answer to “What is your associated tumors are retinal and or a combination (11.5%). Most in making the diagnosis, as in this diagnosis?” on page 19: central nervous system hemangio- lesions are asymptomatic, but may patient. von Hippel-Lindau disease blastomas, RCC, pheochromocyto- present with vague symptoms of The diagnosis is von Hippel-Lindau ma, pancreatic islet cell tumors, and epigastric pain, diarrhea, dyspepsia, References disease (VHL). Subsequent brain endolymphatic sac tumors.1 Cystic obstructive jaundice, or endocrine 1. Lonser RR, Glenn GM, Walther and renal magnetic resonance im- lesions may also be seen in other and/or exocrine pancreatic insuf- M et al. von Hippel-Lindau disease. aging showed features suggestive viscera such as the liver and ovaries. ficiency. Surgery is required for Lancet. 2003;361:2059-67. of a 5-mm right cerebellar heman- Clinical diagnostic criteria require symptomatic cysts or large pancre- 2. Melmon K, Rosen S Lindau’s gioblastoma and right renal cell the presence of any of these tumors atic neuroendocrine tumors. The disease. Am J Med. 1964;36:595- carcinoma (RCC), respectively. Fun- in a patient with a positive family main causes of death are RCC and 617. doscopy showed bilateral small ret- history, or alternatively, at least two central nervous system hemangio- 3. Hammel PR, Vilgrain V, Terris inal angiomas. Plasma and 24-hour retinal or cerebellar hemangioblas- blastomas.3 Our patient underwent B et al. Pancreatic involvement in urinary metenephrine levels were tomas, or one hemangioblastoma laser therapy for her retinal angi- von Hippel-Lindau disease. The normal. Genetic testing confirmed plus one visceral tumor.2 omas, and is currently undergoing Groupe Francophone d’Etude de la a germline VHL mutation. Pancreatic involvement occurs in close regular surveillance. Clinicians Maladie de von Hippel-Lindau. Gas- VHL is a rare autosomal-dominant 65%-77% of patients with VHL, and should have a high index of suspi- troenterology. 2000;119:1087-95. hereditary multicancer condition may be the sole manifestation in cion for diagnosing VHL in patients characterized by germline muta- 7.6%. Findings include multiple true with multiple pancreatic cysts. Be- [email protected] MDEDGE.COM/GIHEPNEWS • JULY 2019 29 CLASSIFIEDS Also available at MedJobNetwork.com

PROFESSIONAL OPPORTUNITIES

Exciting Opportunity for Gastroenterologists in the Land of Enchantment San Juan Regional Medical Center in Farmington, New Mexico is recruiting Gastroenterologists to provide both outpatient and inpatient services. This opportunity not only brings with it a great place to live, but it offers a caring team committed to offering personalized, compassionate care.

You can look forward to: • Compensation potential of $800,000 • Joint venture opportunity San Juan Regional Medical Center is a non-profit and community governed facility. Farmington offers a temperate four-season climate • Productivity bonus incentive with no cap near the Rocky Mountains with world-class snow skiing, fly fishing, • Bread and Butter GI with ERCP skills golf, hiking and water sports. Easy access to world renowned • 1:3 call Santa Fe Opera, cultural sites, National Parks and monuments. • Lucrative benefit package, including retirement Farmington’s strong sense of community and vibrant Southwest • Sign on and relocation culture make it a great place to pursue a work-life balance. • Student loan repayment • Quality work/life balance

Interested candidates should address their C.V. to: Terri Smith | [email protected] | 888.282.6591 or 505.609.6011 sanjuanregional.com | sjrmcdocs.com

WHERE A LANDSCAPE OF SOUTHERN OREGON OPPORTUNITIES AWAITS A

Gastroenterology Consultants, PC of Medford, Oregon is seeking GASTROENTEROLOGIST another BE/BC Gastroenterologist to join our practice. Gundersen Health System in La Crosse, Wisconsin We are a single specialty group of 8 physicians and 5 mid-level is seeking a BC/BE Gastroenterologist to join its practitioners located in beautiful Southern Oregon. established medical team. • Call 1:8 Practice in our state-of-the-art Endoscopy Center • Ownership opportunity in adjacent endoscopic center and modern outpatient clinic. Outreach services are • 12 month to full partnership provided at our satellite clinics located within an • 5-10 minute commute to work easy drive from La Crosse. In addition, you will have opportunities for clinical research and will be • Award winning prep school, local university actively involved in teaching our Surgical, • Award winning theatre Transitional, and Internal Medicine residents. • Excellent restaurants You’ll join a physician-led, not-for-profit health • World-class outdoor activities system with a top-ranked teaching hospital and • Clean air, clean water one of the largest multi-specialty group practices with about 700 physicians and associate medical • Short trip to Portland, Oregon Coast and San Francisco staff. Visit gundersenhealth.org/MedCareers • Job Type: Full-time Send CV to Kalah Haug For more information, contact Medical Staff Recruitment Gundersen Health System Debbie Nielson at 541-773-5031 [email protected] You may send your CV to or call (608)775-1005. [email protected] Please check our website at

www.gcpcmedford.com EEO/AA/Veterans/Disabilities 30 PRACTICE MANAGEMENT JULY 2019 • GI & HEPATOLOGY NEWS PRACTICE MANAGEMENT TOOLBOX: Prior authorization – a call to action

BY PATRICIA GARCIA, MD, AND to procedures and tests that may time consuming, and frustrating. line the prior authorization process SIMON C. MATHEWS, MD be inappropriately overutilized Social media are rife with ac- in the Medicare Advantage program or no longer the standard of care; counts from physicians who were to relieve the administrative bur- ave you noticed that you and however, current activity suggests forced to cancel planned proce- dens this poses for physicians and your staff are spending more a much broader, indiscriminate dures because the prior authori- help patients receive quicker access Htime on prior authorization approach. For example, insurers zation process took weeks instead to the medical care they need. Al- than in the past? Insurance com- are requiring prior authorization of days, received denials, and later though this legislation addresses panies are increasing the number for whole families of services and found out that procedures were only MA plans, we are hopeful that of Current Procedural Terminolo- procedures. Anthem, the second actually approved, or found them- this will be the first step in requiring gy (CPT®) codes for services and largest insurance company in the selves in peer-to-peer review with health plans to streamline this pro- procedures included in their prior United States, recently added the nonphysicians. Gastroenterologists cess and ease administrative burden. authorization programs. More im- entire family of esophagogastro- have also reported cases of patients Please help us increase support for portantly, they are doing so with- duodenoscopy (EGD) codes to its having flares of inflammatory bow- this bill by contacting your legisla- out providing evidence that this list of procedures requiring prior el disease because of medication approach improves patient safety authorization in 10 states includ- delays related to a cumbersome or decreases unindicated medical ing Calif., Conn., Ind., Ohio, Ky., preauthorization process. AGA and other physician procedures. There is also no trans- Mo., Nev., N.H., Va., and Wisc. A Because prior authorization im- organizations are advocating parency about how these prior conversation earlier this year with pacts gastroenterologists’ ability to authorization processes are devel- the Anthem national prior autho- provide timely care to patients, AGA for regulatory changes related oped, evaluated, or adjusted over rization team revealed that they and the entire physician communi- to how Medicare Advantage time. Physicians and their staff are intend to keep adding codes for all ty have been calling for regulatory pushing back on social media, call- specialties to their prior authoriza- change related to prior authoriza- plans use prior authorization. ing prior authorization programs a tion program, portraying the pro- tion in Medicare Advantage (MA) hassle and citing lengthy waits to cess conducted by AIM Specialty plans to reduce physician burden speak to a physician reviewer who Health® (a wholly owned subsidi- and enhance patient safety and care. tors and asking that they cosponsor. is often not even in their specialty. ary of Anthem), as fast, simple, and Last year, AGA worked with our It will take less than 5 minutes of Historically, insurers have used easy. However, many physicians congressional champions Reps. your time and will have a significant prior authorization to control and their office staff find the prior Phil Roe, MD (R-Tenn.), and Ami effect, given the opposition we face costs, particularly those related authorization process complex, Bera, MD (D-Calif.), to secure 150 from insurers: https://app.govpre- signatures on a letter to the CMS dict.com/portal/grassroots/cam- Administrator requesting the agen- paigns/io77ozaa/take_action. cy provide guidance to MA plans The AGA is working on your be- to ensure that prior authorization half to address prior authorization requirements do not create barriers hassles with private payors, but to to care. be effective we need to hear your One in every three people with experiences. We know private pay- Medicare is enrolled in a Medicare ors continue to develop more and Advantage plan. Under current law, more restrictive prior authorization Principles of GI MA plans may not create inappro- policies covering an increasing priate barriers to care that do not number of services and procedures for the NP and PA already exist within the original without evidence that these actions Medicare program. A recent survey provide benefit to patients. Fre- Learn. Network. Enhance. by the American Medical Associa- quently, these policies are put into tion found that over 90% of physi- action without advance warning Aug. 9–11, 2019 | Chicago, Illinois cian respondents felt that the prior and your reports are the first signs authorization process led to delays we have that a change has been Strengthen your diagnostic and therapeutic skill sets with in care for patients that could neg- made. Reach out to the AGA via the the latest in best practices and evidence-based medicine atively impact clinical outcomes. AGA Community or Twitter to let AGA and other physician organiza- us know what’s happening. We will to help you deliver optimal care to GI patients. tions are advocating for regulatory take your stories directly to the changes related to how MA plans insurance companies and demand use prior authorization. that they work with us to reduce In addition to our regulatory physician burden and improve efforts, the AGA is working with transparency. members of Congress on legislative You may also consider filing a solutions to require the MA plans to complaint with the State Insurance increase transparency, streamline Commissioner. State Insurance the prior authorization process, and Commissioners are responsible for minimize the impact on Medicare regulating the insurance industry beneficiaries. With Dr. Bera, Reps. in their state and can investigate to Susan DelBene, D-Wash., Mike Kel- make sure the laws in their state Register today at nppa.gastro.org/learn. ly, R-Penna., and Roger Marshall, are being followed and providers R-Kans., introduced the Improving and patients are being treated fair- EDU19-54 2680-285EDU_17-2 Seniors Timely Access to Care Act of ly. While insurance law and regu- 2019, legislation that would stream- lation are established at the state MDEDGE.COM/GIHEPNEWS • JULY 2019 PRACTICE MANAGEMENT 31 level, the insurance commissioners Seniors Timely Access to Care Act our patients receive the timely tology, Stanford Medicine (Calif.). are members of the National Asso- of 2019 by contacting your legisla- care they need. Dr. Mathews is a member of the ciation of Insurance Commissioners tors and asking that they cospon- AGA Government Affairs Committee (NAIC), which allows them to coor- sor using this link https://app. Dr. Garcia is a member of the AGA and assistant professor of medicine, dinate insurance regulation among govpredict.com/portal/grassroots/ Practice Management and Eco- gastroenterology, and hepatology, the states and territories. campaigns/io77ozaa/take_action. nomics Committee’s Coverage and Johns Hopkins Medicine, Baltimore. If you decide to file a complaint Together, we can pressure insur- Reimbursement Subcommittee and Neither has conflicts of interest. with your State Insurance Com- ers, Congress, and Medicare to clinical assistant professor of med- missioner, first familiarize yourself relieve physician burden and help icine, gastroenterology, and hepa- [email protected] with your state’s complaint process. Many state insurance commission- ers have a standard complaint form you can download or fill out online. Be sure to keep records of all con- versations and interactions with the insurance company to document the steps you’ve taken to attempt to resolve the issue. Consider creating a log of the dates, times, and nature of your contact with the insurance company. Once you have filed a complaint, the commissioner may send a copy to the insurance company and give them a date by which they must respond. If the commissioner be- lieves the response is sufficient, she or he will send a copy of the insurance company’s response to you. If the commissioner feels the insurance company’s response is inadequate, staff from the com- missioner’s office will work with you and the insurer to resolve the issue. While a report of one negative experience with an insurer may not be enough to illicit action, a pattern of delays and difficulties with an in- surer’s prior authorization process noted by many physicians is likely to catch an Insurance Commission- er’s attention. The NAIC cannot tell a problem is widespread if provid- ers and patients don’t report it to the State Insurance Commissioners. Please reach out to AGA with your stories about prior authoriza- tion problems, consider reporting insurance companies that employ systems that cause undue burden and delay to your State Insurance Commissioner and help us in- crease support for the Improving INDEX OF ADVERTISERS

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