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Diagnosis and Management of Primary Sclerosing Cholangitis

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Diagnosis and Management of Primary Sclerosing Cholangitis AASLD PRACTICE GUIDELINES Diagnosis and Management of Primary Sclerosing Cholangitis Roger Chapman,1 Johan Fevery,2 Anthony Kalloo,3 David M. Nagorney,4 Kirsten Muri Boberg,5 Benjamin Shneider,6 and Gregory J. Gores7 Preamble classification used by the Grading of Recommendation This guideline has been approved by the American Asso- Assessment, Development, and Evaluation (GRADE) ciation for the Study of Liver Diseases and represents the workgroup with minor modifications (Table 1).3 The position of the Association. These recommendations pro- strength of recommendations in the GRADE system are vide a data-supported approach. They are based on the classified as strong (class 1) or weak (class 2). The quality following: (1) formal review and analysis of the recently- of evidence supporting strong or weak recommendations published world literature on the topic (Medline search); is designated by one of three levels: high (level A), mod- (2) American College of Physicians Manual for Assessing erate (level B), or low-quality (level C). Health Practices and Designing Practice Guidelines1; (3) guideline policies, including the AASLD Policy on the Definition and Diagnosis Development and Use of Practice Guidelines and the Definitions. Primary sclerosing cholangitis (PSC) is a American Gastroenterological Association Policy State- chronic, cholestatic liver disease characterized by inflam- ment on Guidelines2; and (4) the experience of the au- mation and fibrosis of both intrahepatic and extrahepatic thors in the specified topic. bile ducts,4 leading to the formation of multifocal bile Intended for use by physicians, these recommenda- duct strictures. PSC is likely an immune mediated, pro- tions suggest preferred approaches to the diagnostic, ther- gressive disorder that eventually develops into cirrhosis, apeutic and preventative aspects of care. They are portal hypertension and hepatic decompensation, in the intended to be flexible, in contrast to standards of care, majority of patients.5 which are inflexible policies to be followed in every case. Small duct PSC is a disease variant which is character- Specific recommendations are based on relevant pub- ized by typical cholestatic and histological features of PSC lished information. To more fully characterize the avail- but normal bile ducts on cholangiography.6 PSC overlap able evidence supporting the recommendations, the syndromes are conditions with diagnostic features of both AASLD Practice Guidelines Committee has adopted the PSC and other immune mediated liver diseases including autoimmune hepatitis and autoimmune pancreatitis.7 All AASLD Practice Guidelines are updated annually. If you are viewing a Secondary sclerosing cholangitis (SSC) is characterized Practice Guideline that is more than 12 months old, please visit www.aasld.org for by a similar multifocal biliary stricturing process due to an update in the material. identifiable causes such as long-term biliary obstruction, Abbreviations: AASLD, American Association for the Study of Liver Diseases; infection, and inflammation which in turn leads to de- AIH, autoimmune hepatitis; CCA, cholangiocarcinoma; ERC, endoscopic retro- 8 grade cholangiography; FISH, fluorescent in situ hybridization; IBD, inflammatory struction of bile ducts and secondary biliary cirrhosis. bowel disease; IgG, immunoglobulin G; MRC, magnetic resonance cholangiogra- Immunoglobulin G4 (IgG4)-positive sclerosing cholan- phy; OLT, orthotopic liver transplantation; OR, odds ratio; PET, positron emission gitis might represent a separate entity.9 tomography; PSC, primary sclerosing cholangitis; SSC, secondary sclerosing cholan- gitis; UC, ulcerative colitis; UDCA, ursodeoxycholic acid. Diagnosis of PSC. A diagnosis of PSC is made in patients From the 1John Radcliffe Hospital, Headington, Oxford, UK; 2Hepatology, Uni- with a cholestatic biochemical profile, when cholangiography versity Hospital Gasthuisberg, Leuven, Belgium; 3Division of Gastroenterology and (e.g., magnetic resonance cholangiography [MRC], endoscopic Hepatology, The Johns Hopkins Hospital, Baltimore, MD; 4Division of Gastroen- terology and General Surgery, Mayo Clinic, Rochester, MN; 5Medical Department, retrograde cholangiography [ERC], percutaneous transhepatic Oslo University Hospital, Rikshospitalet, Oslo, Norway; 6Children’s Hospital of cholangiography) shows characteristic bile duct changes with Pittsburgh of UPMC, Pittsburgh, PA; 7 Division of Gastroenterology and Hepatol- multifocal strictures and segmental dilatations, and secondary ogy, Mayo Clinic, Rochester, MN. causes of sclerosing cholangitis have been excluded.8 Patients Received August 31, 2009; accepted August 31, 2009. Address reprint requests to: Gregory J. Gores, Division of Gastroenterology, Mayo who present with clinical, biochemical and histological features Clinic, Rochester, MN. E-mail: [email protected]. compatible with PSC, but have a normal cholangiogram, are Copyright © 2009 by the American Association for the Study of Liver Diseases. classified as small duct PSC.6 Published online in Wiley InterScience (www.interscience.wiley.com). DOI 10.1002/hep.23294 Differential Diagnosis of PSC Versus SSC. Clinical Potential conflict of interest: Nothing to report. and cholangiographic findings resembling PSC have been 660 HEPATOLOGY, Vol. 51, No. 2, 2010 CHAPMAN ET AL. 661 Table 1. Grading of Recommendations, Assessment, Table 3. Serum Autoantibodies in Primary Sclerosing Development and Evaluation (GRADE) Cholangitis Strength of Antibody Prevalence Recommendation Criteria Anti-neutrophil cytoplasmic antibody 50%–80% Factors influencing the strength of Anti-nuclear antibody 7%–77% the recommendation included the Anti-smooth muscle antibody 13%–20% quality of the evidence, presumed Anti-endothelial cell antibody 35% patient-important outcomes, and Anti-cardiolipin antibody 4%–66% Strong (1) cost Thyroperoxidase 7%–16% Variability in preferences and values, Thyroglobulin 4% or more uncertainty. Rheumatoid factor 15% Recommendation is made with less certainty, higher cost or resource Weak (2) consumption Quality of abdominal discomfort, fatigue, pruritus, and weight Evidence Criteria loss.10 Episodes of cholangitis (i.e., fever and chills) are Further research is unlikely to change very uncommon features at presentation, in the absence confidence in the estimate of the 11 High (A) clinical effect of prior biliary surgery or instrumentation such as ERC. Further research may change Physical examination is abnormal in approximately half Moderate confidence in the estimate of the of symptomatic patients at the time of diagnosis; jaun- (B) clinical effect Further research is very likely to dice, hepatomegaly, and splenomegaly are the most fre- impact confidence on the estimate of quent abnormal findings. Low (C) clinical effect Many patients with PSC are asymptomatic with no physical abnormalities at presentation. The diagnosis is made incidentally when persistently cholestatic liver func- described in patients with choledocholithiasis, surgical tion tests are investigated. Approximately 60%-80% of trauma of the biliary tree, intra-arterial chemotherapy, patients with PSC have concomitant IBD, most often and recurrent pancreatitis.8 Other conditions reported to ulcerative colitis (UC).12 mimic PSC are listed in Table 2. Distinguishing primary Serum Biochemical Tests. Serum biochemical tests from SSC may be challenging because PSC patients may usually indicate cholestasis; elevation of serum alkaline have undergone bile duct surgery or have concomitant phosphatase is the most common biochemical abnormal- intraductal stone disease or even cholangiocarcinoma ity in PSC.5,10,13 However, a normal alkaline phosphatase (CCA). The clinical history, distribution of cholangio- activity does not exclude the diagnosis. Serum amino- graphic findings, and the presence or absence of inflam- transferase levels are elevated in the majority of patients matory bowel disease (IBD), have to be taken into (2-3 times upper limits of normal), but like the alkaline consideration when determining if an abnormal cholan- phosphatase can also be in the normal range. Serum bili- giogram is due to PSC or secondary processes.8 rubin levels are normal at diagnosis in the majority of Signs and Symptoms. The clinical presentation is patients. IgG serum levels are modestly elevated in ap- variable; typical symptoms include right upper quadrant proximately 60% of patients (1.5 times the upper limit of normal).14 Table 2. Secondary Causes of Sclerosing Cholangitis Autoantibodies/Serology. A wide range of autoanti- AIDS cholangiopathy bodies can be detected in the serum of patients with PSC indicating an altered state of immune responsiveness or Cholangiocarcinoma 15 Choledocholithiasis immune regulation. Most are present at low prevalence Diffuse intrahepatic metastasis rates and at relatively low titers (Table 3). They have no Eosinophilic cholangitis role in the routine diagnosis of PSC including the perinu- Hepatic inflammatory pseudotumor Histocytosis X clear antineutrophil cytoplasmic antibody which is non- IgG4-associated cholangitis specific, although it may draw attention to colon Intra-arterial chemotherapy involvement in a cholestatic syndrome. Ischemic cholangitis Mast cell cholangiopathy Imaging Studies. Transabdominal ultrasound (US) is Portal hypertensive biliopathy usually nondiagnostic and may even be normal, although Recurrent pancreatitis bile duct wall thickening and/or focal bile duct dilatations Recurrent pyogenic cholangitis are often identified. However, gallbladder
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