Surgical Sphincteroplasty in 446 Patients

PAPER Surgical Sphincteroplasty in 446 Patients

James A. Madura, MD; James A. Madura II, MD; Stuart Sherman, MD; Glen A. Lehman, MD

Hypothesis: Pancreaticobiliary sphincter disease is re- Results: Excellent or good results were seen in 86.8% liably diagnosed by endoscopic and intraoperative ma- of the patients with sphincter of Oddi dysfunction and nometry. in 63.5% of the patients with pancreas divisum. Com- mon duct and sphincter of Oddi pressures were 0 mm Hg Design: Retrospective review of prospectively col- in all patients after sphincteroplasty. Pancreatic duct and lected data. pancreatic sphincter manometry results were improved in 82.4% of the patients. Biopsy results of the main and Setting: A 400-bed urban university hospital. accessory sphincters demonstrated inflammation and/or fibrosis in 33.9% of ampullae and 43.5% of Patients: Between May 1, 1978, and March 27, 2002, transampullar septa, but this did not correlate with out- 446 patients were treated surgically for dysfunction of come. There was 1 death from a duodenal leak. Compli- the pancreaticobiliary sphincters. There were 376 fe- cations occurred in 34.8% of patients, with pancreatitis males and 70 males (mean±SD age, 41.6±12.5 years). (8.8%), asymptomatic hyperamylasemia (6.0%), and There were 372 patients with sphincter of Oddi dysfunc- wound/abdominal infection (7.1%) the most common. Predictive factors for good outcome were reduction in tion, and 74 with pancreas divisum. Symptoms in- pancreatic duct and sphincter pressures following cluded abdominal pain (100.0%), nausea/vomiting sphincteroplasty. (80.5%), back pain (57.2%), and pancreatitis (22.4%). Conclusion: Good to excellent results may be achieved Interventions: Perfusion manometry has evolved as the by surgical sphincteroplasty when careful patient selec- gold standard for diagnosis, and intraoperative manom- tion by manometry is used. etry was done in 214 patients. All patients underwent transduodenal sphincteroplasty and biopsies of the ampullae and transampullar septa. Arch Surg. 2005;140:504-513

RANSDUODENAL SPHINC- 3-mm probe through the ampulla, and (3) teroplasty for stenosis of the an abnormal-appearing ampulloduodenal biliopancreatic sphincters junction on cholangiography. Subse- never achieved popularity quently, in patients with postcholecystec- because of lack of specific tomy biliary type symptoms, noninvasive di- diagnostic tools and criteria for opera- agnostic methods were proposed by Nardi T 1 tion. Once endoscopists developed the ca- and Acosta, with the morphine sulfate– pability to make a more secure diagnosis, neostigmine methylsulfate (Prostigmin) they quickly developed techniques to treat provocative test, but its lack of specificity the sphincter problems nonoperatively. resulted in skepticism in the surgical com- munity. However, there are recent reports See Invited Critique of its continuing use as a screening test, with good correlation with outcome. Intraop- at end of article erative biliary manometry and debimetry, as originally described by Caroli2 and later The surgical approach to the biliary modified by White et al,3 enjoyed some sphincteric mechanism originated in the late popularity but required an open surgical 19th century when it was used to extract procedure and again lacked specificity. No- otherwise irretrievable gallstones im- tably, abnormalities in the pancreatic duct pacted in the ampulla of Vater. However, and its sphincter were unable to be de- Author Affiliations: application of surgical sphincterotomy in the tected. It was not until the advent of endo- Departments of Surgery therapy of chronic pancreatitis was not as (Drs J. A. Madura and scopic retrograde cholangiopancreato- J. A. Madura II) and Medicine successful. Many surgeons reported (1) us- graphy (ERCP) and transendoscopic (Drs Sherman and Lehman), ing subjective evidence of sphincter dis- manometry that a reproducible effort The Indiana University Medical ease intraoperatively, such as a fibrotic- evolved to demonstrate anatomical and Center, Indianapolis. feeling ampulla, (2) failure to easily pass a pathophysiologic causes for the diagnosis

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©2005 American Medical Association. All rights reserved. Downloaded From: https://jamanetwork.com/ on 09/26/2021 of these disorders. As technology developed, hyperten- samples were obtained before the injection and at 30-minute sive and fibrotic pancreaticobiliary sphincters were not only intervals thereafter for 4 hours. The samples were analyzed for identified but were treated therapeutically by endosco- amylase, lipase, aspartate aminotransferase, and alanine ami- pists. notransferase levels. The patients were also monitored for symp- This report details the surgical approach to pancre- toms of typical upper abdominal pain, nausea, and/or vomiting. A result was considered positive if the enzyme levels atic and biliary sphincters during the past 2 decades of increased by greater than 4 times the baseline values. the 20th century, and presents an experience with many The modified Caroli apparatus described by White et al3 was patients studied and treated by a team of gastroenterolo- attached via sterile intravenous tubing to a Silastic ventricular gists and a single surgeon (James A. Mudura). catheter carefully positioned in the supra-ampullary common duct. Two 1-minute measurements of the rate of flow of iso- METHODS tonic sodium chloride solution through the common bile duct were obtained, followed by measurement of the height of the column of isotonic sodium chloride solution remaining in PATIENTS the tubing. Normal flow was accepted as a mean±SD of 23±7 mL/min of isotonic sodium chloride solution, and normal pres- Between May 1, 1978, and March 27, 2002, 446 patients under- sure as a mean±SD of 11±4 mL of isotonic sodium chloride went transduodenal sphincteroplasty for stenosis or other abnor- solution. malities of the pancreaticobiliary sphincters. There were 376 fe- Low-flow perfusion capillary manometry was done intra- males and 70 males (mean±SD age, 41.6±12.5 years; range, 7-74 operatively with equipment similar to that used in endoscopic years). Of the 372 patients diagnosed as having sphincter of Oddi biliopancreatic manometry. A triple-lumen side perfusion cath- dysfunction (SOD), 100 were patients who had previously un- eter was inserted into the biliary and pancreatic ducts and slowly dergone sphincter ablation either endoscopically (n=73) or sur- withdrawn. It was attached to a low-pressure capillary perfu- gically (n=27). In the 74 patients with pancreas divisum (PD), sion device (Arndorfer Medical, Greenvale, Wis) that was con- 33 underwent previous sphincterotomy or sphincteroplasty. nected to an 8-channel data recorder (model MMS 200; Narco The patients’ symptoms had been present for an average of Biosystems, Austin, Tex). Serial pressures were recorded in the 35 months, and included abdominal pain in 100.0%, nausea biliary and pancreatic ducts and in their respective sphincters. and/or vomiting in 80.5%, referred back pain in 57.2%, diar- Results were compared with published standard basal pres- rhea in 25.8%, and documented pancreatitis in 22.4%. Other sures. The accepted norm for the diagnosis of SOD is a mean reported symptoms included weight loss in 17.7% and fatty food basal pressure higher than 40 mm Hg in the sphincter of Oddi intolerance in 23.8%. Prior operations included cholecystec- and the pancreatic sphincter. A pancreatic duct mean basal pres- tomy in 71.1%, gynecologic operations in 47.5%, and appen- sure of 24 mm Hg was accepted as the upper limit of normal in dectomy in 41.3%. Of all patients, 81.6% underwent preopera- these patients. tive ERCP, but not all underwent transendoscopic manometry. Cholecystectomy was performed in all patients who had not In addition, most patients underwent numerous investigative undergone it previously. Transduodenal sphincteroplasty was studies preoperatively to rule out other intra-abdominal dis- performed in a standard fashion through a longitudinal duo- ease as a source for their symptoms. denal incision centered over the major ampulla. The pancre- Initially in this group of patients, the morphine-neostigmine 1 atic orifice was identified and intubated with a metallic probe provocative test, as described by Nardi and Acosta, was done in to prevent pancreatic ductal occlusion during the biliary sphinc- 290 patients. Seventy-one patients consented to a postoperative teroplasty. The choledochal and duodenal mucosae were ap- test. Intraoperative evaluation of the sphincter of Oddi was done 3 proximated with fine absorbable sutures. Pancreatic duct and using a modified Caroli apparatus, as described by White et al, sphincter manometry was then performed, and data were re- in those patients suspected of having stenotic biliary pancreatic corded. If the initial pancreatic duct pressure was lower than sphincter mechanisms and in other patients undergoing routine 24 mm Hg, pancreatic duct sphincteroplasty was not done, which biliary surgery. Those patients with elevated common duct pres- occurred in 11 patients. Next, the pancreatic ductal orifice was sures and diminished transsphincteric flow were considered ap- opened and its edges were sewn to the choledochal mucosa with propriate candidates for transduodenal sphincteroplasty. All pa- synthetic nonabsorbable sutures. Finally, pancreatic duct and tients underwent intraoperative cholangiography to rule out pancreatic sphincter zone pressure measurements were ob- unsuspected or retained common duct stones or abnormal cho- tained again to ensure that these pressures had been appropri- ledochal anatomical features. ately reduced to normal. Other tests, such as secretin-stimulated ultrasonography of In patients with PD, a “dual sphincteroplasty” was done. Fol- the pancreatic duct and ERCP contrast clearing times, were used, lowing cholecystectomy, the major ampulla was opened and a but were inconsistent and frequently nondiagnostic. Transen- biliary sphincteroplasty was done. The duct of Wirsung was doscopic pancreaticobiliary manometry eventually became the not routinely opened because it is usually rudimentary in pa- diagnostic method of choice. A pilot study comparing endo- tients with PD. Next, the accessory ampulla was identified and scopic with intraoperative ductal manometry demonstrated a posi- intubated with a lacrimal duct probe. If identification was dif- tive correlation between the 2 methods, and endoscopic ma- 4 ficult, synthetic secretin was administered intravenously. Pres- nometry subsequently replaced the previous diagnostic methods. sures were recorded if the manometry catheter was able to be All patients were followed up postoperatively for several freely inserted without impacting in the duct. The accessory months if they were totally relieved of their symptoms, and re- ampulla was opened in a medial and cephalad direction, and examined clinically, up to and including repeat ERCP, if symp- the cut edges of the duct were approximated to the duodenal toms persisted or recurred months or years later. mucosa with synthetic nonabsorbable sutures. Biopsy specimens of the ampullary sphincter, pancreatic PROCEDURES duct sphincter (transampullar septum), and accessory sphincters (in the case of PD) were routinely obtained and submitted The morphine-neostigmine test was performed in the manner for histopathologic examination, and the results of the biopsies described by Nardi and Acosta.1 Patients received an injection were reported as normal or abnormal with fibrosis and/or of 10 mg of morphine and 1 mg of neostigmine; venous blood inflammation.

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©2005 American Medical Association. All rights reserved. Downloaded From: https://jamanetwork.com/ on 09/26/2021 Table 1. Complications in 446 Patients Undergoing Transduodenal Sphincteroplasty Between 1978 and 2002*

Those With SOD Those With Pancreas Divisum

Initial Procedure Reoperation Initial Procedure Reoperation Type of Complication (n = 272) (n = 100) (n = 41) (n = 33) Death 0.4 0 0 0 Overall complications 32.4 30.0 56.1 42.4 Pancreatitis 7.7 5.0 22.0 18.2 Hyperamylasemia 3.7 10.0 2.4 21.2 Abdominal or wound infection 7.7 7.0 12.2 0 Duodenal leak 1.8 0 2.4 0 Bile leak 1.8 1.0 0 0 Pulmonary complication 4.8 2.0 4.9 0 Urinary tract infection 1.8 3.0 7.3 0 DVT or PE 0.4 0 2.4 0

Abbreviations: DVT, deep venous thrombosis; PE, pulmonary embolism; SOD, sphincter of Oddi dysfunction. *Data are given as percentage of each group.

Table 2. Results of Transduodenal Sphincteroplasty in 446 Patients Between 1978 and 2002

Result* Total No. Group of Patients Excellent Good Fair Poor Those with SOD Initial procedure 272 190 (69.9) 55 (20.2) 27 (9.9) 0 Reoperation 100 59 (59.0) 19 (19.0) 20 (20.0) 2 (2.0) Those with pancreas divisum Initial procedure 41 15 (36.6) 11 (26.8) 14 (34.1) 1 (2.4) Reoperation 33 14 (42.4) 7 (6.4) 8 (24.2) 4 (12.1) Total 446 278 (62.3) 92 (20.6) 69 (15.5) 7 (1.6)

Abbreviation: SOD, sphincter of Oddi dysfunction. *Data are given as number (percentage) of each group.

All patients experienced drainage of the right upper quad- transendoscopic, tended to do better, but not statistically rant with a Penrose drain, which was removed when the pa- so (Table 2). No restenosis of the major ampulla was seen tient resumed oral nutrition without evidence of an enteric or during this experience, but restenosis of the pancreatic duct biliary leak. or accessory papilla was an occasional problem requiring Collected data were compared where appropriate statisti- either repeat ERCP with endoscopic sphincterotomy and cally by t test, ␹2 analysis, or regression analysis. stenting or reoperation. In the 100 patients who underwent repeat sphincteroplasty, 73 had previously under- RESULTS gone 1 or more transendoscopic sphincterotomies, while the other 27 had been treated surgically. There was a single death in the entire group of 446 patients (0.2%). This occurred early in the series, follow- EVOCATIVE TEST ing a duodenal leak, sepsis, and multisystem organ failure. Complications were seen in 34.8% of the patients, Morphine-neostigmine evocative tests were done in 290 pa- the most serious being pancreatitis, duodenal or bile leak, tients preoperatively and 71 patients postoperatively. Postin- wound infection, and abdominal abscess, which oc- jection symptoms occurred in 91.6% of the patients tested, curred in 20.8%. Other less serious complications, such but only 46.7% had serum lipase levels elevated greater than as urinary tract infection, atelectasis, deep venous throm- 4-fold over the baseline value. Mean enzyme variables (amy- bosis, asymptomatic hyperamylasemia, and prolonged il- lase, lipase, aspartate aminotransferase, and alanine ami- eus, occurred in 14.0% of the patients (Table 1). notransferase levels) were significantly reduced postop- Long-term outcome was considered excellent to good eratively when compared by the t test (PϽ.001). in 82.9% of all patients, and fair to poor in the remaining 17.1%. Of the patients with the usual anatomical features, 86.8% had an excellent or good outcome, while 63.5% of CAROLI MANOMETRY AND DEBIMETRY those with PD, either initially or at reoperation, achieved an excellent to good outcome. Patients who had not un- Caroli pressures were more than 15 cm of isotonic so- dergone previous sphincteric surgery, either surgical or dium chloride solution in 47.2% of the patients, while

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©2005 American Medical Association. All rights reserved. Downloaded From: https://jamanetwork.com/ on 09/26/2021 80 Before Sphincteroplasty Table 3. Intraoperative Manometric Pressures in the After Sphincteroplasty Pancreatic and Biliary Ducts and Sphincters in Patients 70 Undergoing Transduodenal Sphincteroplasty

60 55.2 Basal Recorded Pressure, 50 Mean ± SD, mm Hg*

40 No. of Before After 30.6 30.2 Location Patients Sphincteroplasty Sphincteroplasty 30 26.1 Those With an Initial Procedure for SOD Basal Pressure, mm Hg 20 17.7 Common duct 144 9.9 ± 9.5 0 9.9 Ampulla 139 30.9 ± 29.4 0 10 Pancreatic duct 143 30.1 ± 28.2 17.7 ± 13.5 0 0 Pancreatic sphincter 141 55.3 ± 33.3 25.9 ± 32.3 0 CBD Ampulla PD Pancreatic Sphincter Those With a Reoperation for SOD Common duct 45 7.0 ± 6.7 0 Ampulla 43 18.4 ± 25.6 0 Figure. Mean basal pressure measured intraoperatively before and after Pancreatic duct 49 45.2 ± 48.4 23.7 ± 17.0 sphincteroplasty in 144 patients with dysfunction of the sphincter of Oddi. P=.001 for the difference between all variables before and after Pancreatic sphincter 40 61.4 ± 44.4 31.0 ± 29.5 sphincteroplasty. CBD indicates common bile duct; PD, pancreas divisum. Those With a Procedure for Pancreas Divisum Common duct 17 9.8 ± 6.2 0 Ampulla 17 27.5 ± 19.7 0 the corresponding 1-minute flows of isotonic sodium Pancreatic duct 13 30.1 ± 23.0 16.7 ± 10.2 chloride solution were less than 15 mL/min in 19.0% of Pancreatic sphincter 13 55.2 ± 29.9 34.7 ± 16.6 the patients. In the reoperative patients, however, all Abbreviation: SOD, sphincter of Oddi dysfunction. flows were in the normal range, suggesting that the pre- *PϽ.001, by t test, for all differences in pressure before and after vious surgical sphincteroplasty or endoscopic sphinc- sphincteroplasty. terotomy had left a widely patent sphincter of Oddi. Neither pressure nor flow correlated well with a better result. ingly, in patients with PD, 80.9% of the 22 excised gallbladders demonstrated evidence of chronic inflamma- PRESSURE RESULTS tion. Abnormal histopathologic features did not correlate All patients undergoing major ampullary sphinctero- statistically with clinical outcome, suggesting that pa- plasty had manometric pressures reduced to 0 mm Hg tients with negative histopathologic features did as well (Figure). The pancreatic sphincter and ductal pres- as the others because a fibrotic or inflamed sphincter was sures were significantly reduced in 82.4% of the pa- not necessarily the only cause for symptoms in these patients (Table 3). In 25 patients with small pancreatic tients. ducts, postsphincterotomy pressures were actually in- One patient undergoing sphincteroplasty during this creased by impaction of all 3 orifices of the triple-lumen time, but not included in this series, had a previously un- pressure catheters, despite the orifices being located in recognized small adenocarcinoma of the ampulla on the different radial positions on the catheter tip. Anatomi- postoperative pathology report. He underwent pancre- cally, this was thought to occur at the pancreatic ductal atoduodenectomy and has survived for 17 years postop- genu, where the junction of the ventral and dorsal ducts eratively. occurred.

PATHOLOGICAL RESULTS COMMENT

In 55.8% of the patients, the final pathological finding The cause of pancreaticobiliary sphincter dysfunction can of the major ampullary sphincter was reported as nega- be divided into several categories. The sphincter of the tive for fibrosis and/or inflammation. In the transampul- major ampulla is most frequently injured by the passage lar septum, 56.6% of the specimens were observed to be of gallstones from the gallbladder through the common normal. In patients with PD, 58.5% of accessory ampul- bile duct and the ampulla of Vater. The impaction of stones lary biopsy results were reported as normal (Table 4). in this ampulla may also cause inflammation and scar- An explanation for this many normal biopsy results might ring in the orifice of the main pancreatic duct and its be sampling error, although that would be unusual in sphincter, resulting in increased pancreatic ductal pres- many cases done in the same way by a single surgeon. A sure to overcome the obstruction caused by the inflam- more plausible explanation might be that not all of the mation and fibrosis. Alternatively, some sphincters might patients had a fibrotic and stenotic sphincter, despite el- be hypersensitive to various noxious stimuli, such as al- evated pressure, but perhaps a hyperplastic or hypersen- cohol, other drugs, or a hormonal secretion, resulting in sitive sphincter was the cause. In patients undergoing cho- elevated ampullary pressures, but without the charac- lecystectomy as part of the procedure, chronic cholecystitis teristic fibrotic and inflamed histopathologic picture seen was seen in 78.3% of removed gallbladders. Interest- following the passage of stones. Only a few investiga-

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©2005 American Medical Association. All rights reserved. Downloaded From: https://jamanetwork.com/ on 09/26/2021 Table 4. Histopathologic Findings of the Biliopancreatic Ampullae and Sphincters in Patients Undergoing Sphincteroplasty

Histopathologic Findings* No. of Biopsies/ Group No. of Patients Normal Inflammation Fibrosis Ampulla of Vater Those with SOD Initial procedure 255/272 155 (60.8) 74 (29.0) 26 (10.2) Reoperation 87/100 50 (57.5) 26 (29.9) 11 (12.6) Those with pancreas divisum Initial procedure 40/41 29 (72.5) 8 (20.0) 3 (7.5) Reoperation 18/33 15 (83.3) 3 (16.7) 0 Transampullary Septum Those with SOD Initial procedure 234/272 135 (57.7) 35 (15.0) 64 (27.3) Reoperation 84/100 34 (40.5) 21 (25.0) 29 (34.5) Those with pancreas divisum Initial procedure 36/41 27 (75.0) 7 (19.4) 2 (5.6) Reoperation 12/33 11 (91.7) 1 (8.3) 0 Accessory Ampulla Those with pancreas divisum Initial procedure 29/41 19 (65.5) 10 (34.5) 0 Reoperation 24/33 12 (50.0) 11 (45.8) 1 (4.2)

Abbreviation: SOD, sphincter of Oddi dysfunction. *Data are given as number (percentage) of each group. Percentages may not total 100 because of rounding. Denominators used were the number of biopsies for each group.

tors have performed a biopsy of the ampulla in these pa- ported more than 100 years ago. In the mid 20th cen- tients, and have observed not only fibrosis and inflam- tury, with the increasingly frequent removal of the gall- mation but also muscular hypertrophy in many of the bladder, postcholecystectomy surgical symptoms similar studied specimens.5-7 Several of these series reported many to the original biliary pain occurred in 10% to 20% of specimens with a normal histopathologic appearance, as patients and renewed interest in the pancreaticobiliary was seen in the present group of patients. sphincters, initiating a search for accurate methods to di- In the 7% to 10% of patients who have PD with dor- agnose and treat such symptoms. In the pre-ERCP era, sal duct prominence and symptoms of pancreatitis, the no reliable techniques were available preoperatively to orifice of the accessory duct may be congenitally insuf- provide a reasonable certainty that these sphincters were ficient to allow passage of the increasing amounts of pan- indeed the source of the symptoms and, therefore, sug- creatic secretion seen as the individual grows and pan- gestions that potentially risky surgical procedures be done creas function increases proportionately. There certainly were met with much skepticism in the surgical and medi- is a different mechanism than is seen in the major pa- cal communities. During this era, surgeons examined pilla, where gallstone transit accounts for much of the symptomatic patients intraoperatively by palpation of the dysfunction. A small and tight minor papillary orifice is sphincter through the duodenal wall or by the inability frequently observed when the accessory duct in a dor- to pass a 3-mm dilator through the ampulla into the duo- sally dominant system can barely be located and intuba- denum. Others relied on the cholangiographic appear- tion of its orifice can only be accomplished with the fin- ance of a tapered choledochal-duodenal junction or on est of lacrimal duct probes or the adjunctive use of secretin, a dilated common bile duct. Because these were largely despite a dilated dorsal duct. The reported results of sur- subjective measures, the surgical approach to the sphinc- gical treatment for PD are not quite as favorable as for ter of Oddi was not widely accepted, despite good re- SOD, because the problem is congenital and may take sults reported by respected researchers.9-13 The evolu- longer to cause recurrent and undetected bouts of pan- tion of sphincter ablation from sphincterotomy to creatitis. sphincteroplasty to biliopancreatic sphincteroplasty Endoscopic retrograde cholangiopancreatography and seemed to result in better outcomes, yet a definitive pre- subsequent transendoscopic manometry studies have operative selection tool remained elusive14,15 (Table 5). demonstrated hypertension in the biliary and pancre- The morphine-neostigmine evocative test was an early atic sphincters.8 Skilled endoscopists routinely perform attempt to select such patients, but was subsequently such evaluations and are able to reliably apply these meth- proved too nonspecific by several investigators.26,27 Nev- ods to diagnose conditions in patients with postchole- ertheless, several recent reports suggest using this evoca- cystectomy symptoms, unexplained upper abdominal tive test as a screening tool in patients with typical post- pain, and idiopathic pancreatitis. cholecystectomy symptoms. Caroli2 and White et al3 Early surgical approaches to the sphincter to remove published their efforts to define abnormal sphincteric stones impacted in the distal common duct were re- function (radiomanometry) and select patients for sur-

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Source No. of Patients Excellent or Good Result, % Morbidity, % Mortality, % Kozloff and Joseph,16 1975 65 82 NR 3.0 Partington,10 1977 138 79 NR 2.9 Madura et al,17 1981 50 88 28 2.0 Bagley et al,11 1981 67 64 9 6.0 Nardi et al,9 1983 95 48 NR 4.2 Anderson et al,18 1985 56 77 28 5.7 Hastbacka et al,19 1986 22 60 18 0 Stephens and Burdick,20 1986 81 68 7 1.2 Duca,21 1989 70 97 7 1.4 Nussbaum et al,22 1989 29 62 38 0 Moody et al,15 1991 86 75 23 0.8 Azabache Puente and Saavedra,23 1992 58 95 25 1.7 Kelly and Rowlands,24 1996 20 65 25 0 Toouli et al,25 1996 26 58 12 0 Overall 863 74.1 20.0 1.9

Abbreviation: NR, data not reported.

Table 6. Results of Endoscopic Sphincterotomy Reported Between 1981 and 2003

Source No. of Patients Excellent or Good Result, % Morbidity, % Mortality, % Rosch et al,32 1981 37 86 4.6 1.3 Riemann et al,33 1983 25 80 13.0 0 Tanaka et al,34 1985 12 66 0 0 Neoptolemos et al,35 1987 30 70 25.0 0 Thatcher et al,36 1987 51 77 15.6 0 Guelrud,37 1988 17 65 NR NR Geenen et al,38 1989 23 65 8.7 0 Weitemeyer,39 1994 247 82 28.3 0 Hwang et al,40 1996 24 71 8.3 0 Tzovaras and Rowlands,41 1998 36 84 44.4 0 Toouli and Craig,42 2000 37 62 21.6 0 Cicala et al,43 2002 14 93 NR NR Park et al,44 2003 313 75 15.0 0 Overall 866 77.0 16.8 0.12

Abbreviation: NR, data not reported.

gical sphincterotomy. Other investigators using these tech- copists at major referral centers to perform more transen- niques duplicated these studies, but acknowledged that doscopic sphincterotomies for SOD, and their results are these measurements did not really address the pancre- similar to those of surgical transduodenal sphinctero- atic sphincter and duct.17 However, it was not until en- plasty31 (Table 6). doscopic retrograde access to the pancreaticobiliary sys- The prevalence of sphincteric dysfunction in the gen- tem was available in humans that the diagnosis of stenotic eral population is not really known because most re- or hypertensive sphincteric diseases began to be ac- ports are from a few centers specializing in the diagno- cepted. Classen and Demling28 and Kawai et al29 are cred- sis and management of pancreaticobiliary disease. It is ited with independently describing endoscopic sphinc- reported that more than 10 000 endoscopic sphincter- terotomy in 1974, but the technique was primarily used otomies have been done, with more than 95% done for to extract retained common duct stones. Low-pressure common duct stone extraction; and it has become clear perfusion catheters and recording devices were used to that patients undergoing procedures for SOD do not do identify patients with symptoms of pancreaticobiliary dis- as well as patients undergoing endoscopic sphincteroto- ease, who had findings of dysfunction that could be ad- mies for stone retrieval, especially when the procedures dressed.8 Hogan and Geenen30 created a classification sys- are done by endoscopists with limited experience.45 De- tem and demonstrated that patients with symptoms of spite the popularity and acceptance of this nonoper- partial obstruction to biliary and pancreatic flow who had ative approach, a significant complication rate is ac- elevated sphincteric pressures obtained significant re- knowledged.46,47 Pancreatitis rates up to 20% have been lief from sphincterotomy, when compared with patients reported, and several early series reported 1% to 2% mor- who had symptoms but no objective findings. During the tality. In addition, recurrent stenosis is reported in up past decade, increasing experience has led skilled endos- to 25% to 33% of patients. Other significant complica-

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©2005 American Medical Association. All rights reserved. Downloaded From: https://jamanetwork.com/ on 09/26/2021 tions include duodenal perforation, intraluminal hem- doscopic sphincterotomy, but there is significant mor- orrhage at the sphincterotomy site, and pancreatic duct bidity and occasional pancreatitis-related mortality. In strictures. Restenosis of the pancreatic duct orifice has addition, recurrent stenosis of the pancreatic duct oc- been a problem reported after long-term stenting with curs with greater frequency than was seen in the surgi- polyethylene or other prostheses, and has led to focal- cal sphincteroplasty era. Surgeons may then be called on sclerosing pancreatitis in the head of the pancreas, re- to treat these difficult clinical problems. In areas in which quiring subsequent pancreaticoenteric anastomosis or re- skilled endoscopic therapists are not available, sur- section in some patients.48,49 geons may be required to be the primary therapist and The use of intraoperative manometry allowed us to should be prepared to study these patients with intraop- assess the patients with suspected dysfunctional pancre- erative manometry, not only to ensure that the diagno- aticobiliary sphincters in the major and minor papilla. sis is correct but that surgical treatment is adequate. Prepa- In addition, immediate postsphincteroplasty manom- ration for these operations requires equipment and etry ensured that the abnormal pressures were in fact re- knowledge of its use. If done appropriately, transduode- duced to normal levels. As previously mentioned, once nal sphincteroplasty can be done reliably, with minimal the choledochal sphincter was ablated, the pancreatic duct morbidity and mortality, with equal or better results than and its sphincter could be tested for increased pres- those observed endoscopically. sures, and if the pressures were normal or subnormal, as they were in some cases, then no pancreatic sphincteroplasty was done. Because both ducts drain through Accepted for Publication: January 18, 2005. the main ampulla in 90% of patients, a more distal sphinc- Correspondence: James A. Madura, MD, 9525 Copley ter obstruction could affect both orifices, and the pres- Dr, Indianapolis, IN 46260 ([email protected]). sures in the pancreas and biliary tree could be dimin- Previous Presentation: This paper was presented at the ished by sphincter ablation of the major ampulla alone. Annual Scientific Meeting of the Western Surgical As- In centers with skilled endoscopists, few sphinctero- sociation; November 8, 2004; Las Vegas, Nev; and is pub- plasties are referred to surgeons. The technical revolu- lished after peer review and revision. The discussions that tion limiting biliary tract surgical experience to chole- follow this article are based on the originally submitted cystectomy has eliminated routine intraoperative manuscript and not the revised manuscript. cholangiography, and no efforts are made to evaluate the sphincteric mechanism. There do remain situations in REFERENCES which the biliopancreatic ampullae are unreachable by endoscopy, such as following gastric restrictive proce- 1. Nardi GL, Acosta JM. Papillitis as a cause of pancreatitis and abdominal pain: dures for obesity and in patients who have undergone role of evocative test, operative pancreatography and histologic evaluation. Ann Surg. 1966;164:611-621. gastric resection with Billroth II or Roux-en-Y recon- 2. Caroli J. La radiomanometrie biliare. Sem Hop Paris. 1946;21:1278-1282. struction. These patients are unable to be diagnosed en- 3. White TT, Waisman H, Hopton D, et al. Radiomanometry, flow rates, and chol- doscopically, and endoscopic sphincterotomy is impos- angiography in the evaluation of common bile duct disease: a study of 220 cases. sible as well. In this situation, the surgeon may be called Am J Surg. 1972;123:73-79. on to approach this area via open laparotomy, and, given 4. Sherman S, Hawes RH, Madura JA, Lehman GA. Comparison of intraoperative and endoscopic manometry of the sphincter of Oddi. Surg Gynecol Obstet. 1992; lack of experience and the equipment necessary to mea- 175:410-418. sure ductal and sphincteric pressures, he or she may be 5. Acosta JM, Nardi GL. Papillitis: inflammatory disease of the ampulla of Vater. only able to do a “blind” transduodenal sphinctero- Arch Surg. 1966;92:354-361. plasty without subjective evidence before or after the pro- 6. Paulino F, Cavalcanti A. Biopsy of the ampulla of Vater for demonstration of or- ganic stenosis. Surgery. 1960;48:698-705. cedure. 7. Ponchon T, Aucia N, Mitchell R, et al. Biopsies of the ampullary region in pa- The therapy of pancreaticobiliary sphincter dysfunc- tients suspected to have sphincter of Oddi dysfunction. Gastrointest Endosc. 1995; tion is still evolving. Transendoscopic diagnostic meth- 42:296-300. ods can identify with certainty patients with symptoms 8. Geenen JE, Hogan WJ, Dodds WJ, et al. Intraluminal pressure recording from and abnormal manometry results. The endoscopic re- the human sphincter of Oddi. Gastroenterology. 1980;78:317-324. 9. Nardi GL, Michelassi F, Zannini P. Transduodenal sphincteroplasty: 5-25 year sults of treatment in carefully selected patients are uni- follow-up of 89 patients. Ann Surg. 1983;198:453-461. formly good, at least in the short-term (Table 4). Transen- 10. Partington PF. Twenty-three years of experience with sphincterotomy and sphinc- doscopic sphincterotomy is done much more frequently teroplasty for stenosis of the sphincter of Oddi. Surg Gynecol Obstet. 1977; than surgical sphincteroplasty ever was; however, the pit- 145:161-168. 11. Bagley FH, Braasch JW, Taylor RH, et al. Sphincterotomy or sphincteroplasty in falls observed in surgical sphincterotomy remain (ie, with- the treatment of pathologically mild chronic pancreatitis. Am J Surg. 1981; out suturing the ducts open, restenosis will occur in many 141:418-422. patients). The routine placement of pancreatic duct stents 12. Jones SA, Steedman RA, Keller TB, Smith LL. Transduodenal sphincteroplasty in major and minor papillae after endoscopic sphincter- (not sphincterotomy) for biliary and pancreatic disease: indications, contraindi- otomy seems to contribute to recurrent pancreatic duc- cations, and results. Am J Surg. 1969;118:292-306. 13. Moody FG, Calabuig R, Vecchio R, Runkel N. Stenosis of the sphincter of Oddi. tal obstruction and symptomatic chronic pancreatitis. Surg Clin North Am. 1990;70:1341-1354. In conclusion, patients with primary or postcholecys- 14. Jones SA. Sphincteroplasty (not sphincterotomy) in the treatment of biliary tract tectomy symptoms of upper abdominal pain, nausea, disease. Surg Clin North Am. 1973;53:1123-1137. and/or vomiting may elude diagnosis of their problem. 15. Moody FG, Vecchio R, Calabuig R, et al. Transduodenal sphincteroplasty with transampullary septectomy for stenosing papillitis. Am J Surg. 1991;161:213- Many of these patients may be referred for ERCP with 218. manometry results diagnostic of dysfunction of the sphinc- 16. Kozloff L, Joseph WL. Transduodenal sphincteroplasty for biliary tract disease. ter of Oddi. Most of these patients will be treated by en- Am Surg. 1975;41:125-130.

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©2005 American Medical Association. All rights reserved. Downloaded From: https://jamanetwork.com/ on 09/26/2021 17. Madura JA, McCammon RL, Paris JM, et al. The Nardi test and biliary manom- 46. Tzovaras G, Shukla P, Kow L, Mounkley D, Wilson T, Toouli J. What are the risks etry in the diagnosis of pancreaticobiliary sphincter dysfunction. Surgery. 1981; of diagnostic and therapeutic endoscopic retrograde cholangiopancreatography? 90:588-595. Aust NZJSurg. 2000;70:778-782. 18. Anderson TM, Pitt HA, Longmire WP Jr. Experience with sphincteroplasty and 47. Freeman ML. Complications of endoscopic sphincterotomy. Endoscopy. 1998;30: sphincterotomy in pancreatobiliary surgery. Ann Surg. 1985;201:399-406. A216-A220. 19. Hastbacka J, Jarvinen H, Kivilaakso E, et al. Results of sphincteroplasty in pa- 48. Sherman S, Hawes RH, Savides TJ, et al. Stent-induced pancreatic ductal and tients with spastic sphincter of Oddi: predictive value of operative biliary ma- parenchymal changes: correlation of endoscopic ultrasound with ERCP. Gas- nometry and provocation tests. Scand J Gastroenterol. 1986;21:516-520. trointest Endosc. 1996;44:276-282. 20. Stephens RV, Burdick GE. Microscopic transduodenal sphincteroplasty and trans- 49. Alvarez C, Robert M, Sherman S, et al. Histologic changes after stenting of the ampullary septoplasty for papillary stenosis. Am J Surg. 1986;152:621-627. pancreatic duct. Arch Surg. 1994;129:765-768. 21. Duca S. Sphincteroplasty of the sphincter of Oddi in the treatment of benign distal obstructions of the bile duct: a prospective study of 70 cases managed by a original surgical technique. HPB Surg. 1989;1:131-140. DISCUSSION 22. Nussbaum MS, Warner BW, Sax HC, et al. Transduodenal sphincteroplasty and transampullary septotomy for primary sphincter of Oddi dysfunction. Am J Surg. Jack Pickleman, MD, Chicago, Ill: Perhaps some of you in the 1989;157:38-43. audience might question the criteria for selecting a discussant 23. Azabache Puente W, Saavedra CV. Transduodenal sphincteroplasty of the Oddi- for a paper such as this. Let me clarify it for you. First, the dis- Boyden for free bilio-pancreatic flow [in Spanish]. Rev Gastroenterol Peru. 1992; cussant should have heard of the condition. Second, he should 12:123-134. have performed 4 of the procedures in question during his 30- 24. Kelly SB, Rowlands BJ. Transduodenal sphincteroplasty and transampullary sep- year career. Third, he should have a currently beating heart. tectomy for papillary stenosis. HPB Surg. 1996;9:199-207. As such, I am uniquely qualified to stand here today. 25. Toouli J, Di Francesco V, Saccone G, et al. Division of the sphincter of Oddi for In the Old Testament, in the book of Exodus, chapters 7 to treatment of dysfunction associated with recurrent pancreatitis. Br J Surg. 1996; 11, it is related that God visited numerous plagues upon the 83:1205-1210. Egyptians, including frogs, pestilence, boils, hail, darkness, and 26. LoGiudice JA, Geenen JE, Hogan WJ, et al. Efficacy of the morphine-prostigmin the death of all first-born children. To this list of biblical may- test for evaluating patients with suspected papillary stenosis. Dig Dis Sci. 1979; 24:455-458. hem, it would appear that the Hoosier State is now cursed with 27. Steinberg WM, Salvato RF, Toskes PP. The morphine-prostigmin provocative test: yet another misfortune, namely, pancreaticobiliary sphincter is it useful for making clinical decisions? Gastroenterology. 1980;78:728-731. dysfunction, including some 1500 patients with pancreas di- 28. Classen M, Demling L. Endoskopische Spinckterotomie der papilla vateri und Stein- visum seen over a 7-year period, as previously reported by the extraktion aus dem dutus choledochus. Dtsch Med Wochenschr. 1974;99: same authors at this meeting in 2002. One has to wonder what 496-497. transgressions against God were committed by the citizens of 29. Kawai K, Akasaka Y, Murakami K, et al. Endoscopic sphincterotomy of the am- Indiana to cause this current devastation. Could it be that God pulla of Vater. Gastrointest Endosc. 1974;20:148-151. never intended Bobby Knight to become a Texan? 30. Hogan WJ, Geenen JE. Biliary dyskinesia. Endoscopy. 1988;20:179-183. I have several questions for the authors. (1) fifty-six per- 31. Sherman S, Lehman GA, Jamidar P, et al. Efficacy of endoscopic sphincter- cent of your patients had normal biopsies and yet many of these otomy and surgical sphincteroplasty for patients with sphincter of Oddi dysfunction (SOD): randomized, controlled study. Gastrointest Endosc. 1994;40:125. were cured by sphincteroplasty. Could you speculate on the 32. Rosch W, Riemann JF, Lux G, et al. Long-term follow-up after endoscopic etiology of their pancreatic duct hypertension? Also, you noted sphincterotomy. Endoscopy. 1981;13:152-153. that a decrease in postoperative pressures predicted a good clini- 33. Riemann JF, Lux G, Forster P, et al. Long-term results after endoscopic papillotomy. cal outcome. How many patients had no change in pressure Endoscopy. 1983;15(suppl 1):165-168. and yet achieved a good outcome and how do you account for 34. Tanaka M, Ikeda S, Matsumoto S, et al. Manometric diagnosis of sphincter of this? (2) In symptomatic pancreas divisum, do you feel it is nec- Oddi spasm as a cause of postcholecystectomy pain and the treatment by en- essary to perform a dual sphincteroplasty or is a procedure on doscopic sphincterotomy. Ann Surg. 1985;202:712-719. the accessory duct of Santorini alone sufficient? (3) Referring 35. Neoptolemos JP, Davidson BR, Shaw DE, et al. Study of common bile duct ex- back to my designation of these conditions as a unique Indi- ploration and endoscopic sphincterotomy in a consecutive series of 438 patients. ana plague, how do you account for your vast experience with Br J Surg. 1987;74:916-921. 36. Thatcher BS, Sivak MV Jr, Tedesco FJ, et al. Endoscopic sphincterotomy for sus- these 2 conditions, when comparably sized university centers pected dysfunction of the sphincter of Oddi. Gastrointest Endosc. 1987;33: throughout the country have seen relatively few such pa- 91-95. tients? (4) Lastly, in my admittedly very limited experience with 37. Guelrud M. Papillary stenosis. Endoscopy. 1988;20:193-202. this procedure for this condition, I noticed that, after I fin- 38. Geenen JE, Hogan WJ, Dodds WJ, et al. The efficacy of endoscopic sphincter- ished operating on the sphincter, it had the appearance of a pork otomy after cholecystectomy in patients with sphincter-of-Oddi dysfunction. chop attacked by a Chihuahua. Do you have any technical tips N Engl J Med. 1989;320:82-87. to share with the occasional sphincterotomist? 39. Weitemeyer R. The treatment of ampullary stenosis by endoscopic sphincter- Dr Madura: I would like to thank my scripture-spouting dis- otomy (EST). Am J Surg. 1994;167:493-496. cussant and remind Dr Pickleman that one man’s plagues are 40. Hwang JS, Lai KH, Lo GH, et al. The efficacy of endoscopic sphincterotomy in another man’s manna. patients with sphincter of Oddi dysfunction. Zhonghua Yi Xue Za Zhi (Taipei). 1996;57:177-183. I was equally curious that a significant number of our pa- 41. Tzovaras G, Rowlands BJ. Diagnosis and treatment of sphincter of Oddi dysfunction. tients had normal pathology and I thought perhaps I did not Br J Surg. 1998;85:588-595. know how to consistently do an adequate biopsy, but after per- 42. Toouli J, Craig A. Sphincter of Oddi function and dysfunction. Can J Gastroenterol. forming more than 400 procedures you have to assume that if 2000;14:411-419. you are doing them all the same way and getting adequate tis- 43. Cicala M, Habib FI, Vavassori P, et al. Outcome of endoscopic sphincterotomy sue the result must be accurate. I think the problem is that not in post cholecystectomy patients with sphincter of Oddi dysfunction as pre- all of these patients passed gallstones through their sphinc- dicted by manometry and quantitative choledochoscintigraphy. Gut. 2002; ters. If you look at the very few studies in the literature that 50:665-668. have done ampullary biopsies, most of them have a 50% nor- 44. Park SH, Watkins JL, Fogel EL, et al. Long-term outcome of endoscopic dual mal histopathology rate. If the patients were selected by intra- pancreatobiliary sphincterotomy in patients with manometry-documented sphincter of Oddi dysfunction and normal pancreatogram. Gastrointest Endosc. 2003; operative palpation of a very hard ampulla, then you are going 57:483-491. to have a specimen with fibrosis. Endoscopic retrograde chol- 45. Cotton PB, Geenen JE, Sherman S, et al. Endoscopic sphincterotomy for stones angiopancreatography (ERCP) and manometry studies have by experts is safe, even in younger patients with normal ducts. Ann Surg. 1998; shown us that many of these patients do not have a thick fi- 227:201-204. brotic sphincter, but are rather normal appearing, so I would

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©2005 American Medical Association. All rights reserved. Downloaded From: https://jamanetwork.com/ on 09/26/2021 have to say that this is sphincter spasm, congenital hypertro- largest series that they have reported thus far is 300 cases in phy of the muscular layer, or some other unknown cause re- 2003. The endoscopy service has conferences to demonstrate sulting in sphincter dysfunction. When biopsying, you must what they do. I do not think it teaches unskilled endoscopists also remember there are several articles reporting that there are to be skilled, but it opens new lines of referral to our center. a few patients who have an undetected neoplasm of the am- You asked for technical tips to avoid a hamburger- pulla. We had one such patient, who is not included in this se- appearing sphincter. They do look like that when you first start ries, that had an adenocarcinoma of his ampulla, and we did a doing them, but Dr Robert Hermann of The Cleveland Clinic Whipple on him 17 years ago, and he is still alive and well. was a visiting professor when I first started doing these and The pressure studies are a little more complex because we taught me a few important techniques. The idea is to get good were measuring several anatomical sphincters, but 80% of the exposure and do the operation at skin level if the patient is not patients had a reduction in sphincter pressure and this did cor- excessively large. We perform a generous Kocher maneuver and relate with a better outcome. Ten percent had no change in pres- pass a small Bakes dilator through the common duct into the sure, but these were patients who had normal pressures in the duodenum, palpate it, and make as small a longitudinal inci- pancreatic duct, so we did not do a pancreatic sphinctero- sion as possible over the sphincter itself. The most important plasty, thinking we could not improve that, and those patients thing I learned from Dr Hermann was to place a 3-0 silk trac- all did quite well. The other 10% of patients, mostly with pan- tion suture about 1 cm distal to the ampulla and retract it through creas divisum, whose pressures actually increased postsphinc- the duodenal opening and attach it to the patient’s skin or the teroplasty (but I think that was a mechanical problem with the drapes, then you have a wonderfully stable and accessible field triple-lumen catheter that seemed to get impacted in the duct, in which to work. In this way, you can avoid duodenal trauma occluding Ն1 lumina and giving falsely elevated pressure), these from forceps and other grasping instruments. Magnification is patients did about the same as the other pancreas divisum probably important for beginners or people who wear glasses patients. to help locate the orifice of the pancreatic duct. If you cannot Dr Pickleman asked why we did a dual sphincteroplasty in find the pancreatic duct, the use of intravenous secretin is help- the pancreas divisum patients and if it was necessary. We were ful, since it will localize and intermittently dilate the ductal ori- measuring pressures, flows, and manometric pressures in these fice. When identifying the accessory duct, it is usually about 1 patients, and found that many of these patients actually had cm cephalad and 1 cm medial to the major papilla. We used abnormal sphincter of Oddi function. Another reason we did absorbable suture routinely on the choledochal sphinctero- dual sphincteroplasty is that early in our experience we were plasty, and on the pancreatic duct we used polypropylene so not always sure of the diagnosis of pancreas divisum, so once that the endoscopists would have “landing lights” should they we identified the ventral duct a pancreatogram would clench ever need to restudy the ducts. Finally, we always closed the the diagnosis for us. We, therefore, did a procedure that was duodenum longitudinally. We initially used T tubes, but quickly originally described in the early 1970s in which we opened both abandoned that, and we always used an old-fashioned Pen- sphincters. Reviewing published pancreas divisum articles, it rose drain in the right upper quadrant. So that is how our treat- is inconsistent what procedures were done and the reasons for ment evolved in doing this procedure. them. Some did dual sphincteroplasty; some did only the ac- Jeffrey Landercasper, MD, LaCrosse, Wis: Dr Madura, I cessory papilla, while others left gallbladders intact. We thought commend you on such low surgical morbidity and mortality that if we eliminated all chances for recurrent pain we would on over 400 patients undergoing operations on the duodenum be more successful, and so we did dual sphincteroplasties rou- and sphincter. I have a question for you, also about indica- tinely. So it is my opinion that opening both ducts appears to tions. Do you have any data, do you have any information, on be better than accessory ductoplasty alone. a similar cohort of patients diagnosed during this same time The question of the large number of patients seen and op- with manometrically proven sphincter of Oddi dysfunction who erated upon has been raised. These patients were not all from did not undergo either endoscopic sphincterotomy or surgical Indiana, but referred from across the central part of the United sphincterotomy, but rather chose to undergo no treatment or States. It reflects the interest in this disease process at our medi- medical treatment and how they did in long-term follow-up to cal center and the skill and proficiency of our endoscopy team. compare to your group? In reviewing the endoscopic literature, there are a very small Dr Madura: I do not have such information from our cen- handful of centers, mostly in the Midwest and on the East Coast, ter, but there are 2 randomized controlled studies in the lit- that do sizable numbers of ERCPs, manometries, and endo- erature, one by Geenen in Milwaukee and the other by Toouli scopic sphincterotomies. It was estimated a few years ago that of Australia. In both of those reports, they did manometric stud- over 10 000 endoscopic sphincterotomies were done around ies in all patients and then they did a sham sphincterotomy in the world, and 95% were done for stones. Only 5% of endo- one group and a real endoscopic sphincterotomy in the other, scopic sphincterotomies were done for sphincteric dysfunc- and there was definitely a therapeutic advantage to having a tion, and these are done in a few places that have developed sphincterotomy in their patients. And while these are quoted ERCP manometric investigation and safe methods of sphinc- as landmark studies, they contain only 40 or 50 patients in each terotomy. In spite of the thousands of ERCPs and manom- study, but that is what the endoscopy literature considers sig- etries that Drs Lehman and Sherman have done in Indiana, the nificant.

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