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Background and study aim: Pancreatitis following endoscopic retrograde cholangiopancreatography (ERCP) is a significant and potentially life-threatening adverse event and is common in patients with suspected sphincter of Oddi dysfunction (SOD). Here we aimed to identify predictors of the risk in this population. Patients and methods: The Evaluating Predictors and Interventions in SOD (EPISOD) study prospectively enrolled 214 post-cholecystectomy patients with SOD type III in seven US centers. Patients were randomized, using a 2:1 allocation, to sphincterotomy or sham procedure, irrespective of the results of sphincter of Oddi manometry. Patients in the sphincterotomy arm who had elevated pancreatic sphincter pressure were randomized to biliary only or to dual (biliary and pancreatic) sphincterotomy. All but one patient received prophylactic pancreatic stents, but none received pharmacological prophylaxis. Post ERCP pancreatitis (PEP) was defined as acute pancreatitis within the subsequent 7 days. Blinded research coordinators at each site called patients at 1 week post-procedure. Results: PEP occurred in 26 patients, in 10.6 % (15/141) in the sphincterotomy arm and 15.1 % (11/73) in the sham arm; unadjusted relative risk 0.71 (95 % confidence interval [95 %CI] 0.34 – 1.46). PEP rate was not significantly different in patients who received sphincterotomy compared with those undergoing sham treatment. In addition, the proportion was not statistically different in those who received biliary sphincterotomy alone (12/94; 12.8 % [95 %CI 6.0 % – 19.5 %]) compared with dual sphincterotomy (3/47; 6.4 % [95 %CI 0.0 % – 13.4 %]). Multivariate analysis identified an interaction between duration of ERCP and sedation type (P Conclusion: The performance of biliary or dual sphincterotomy does not increase the risk of PEP in patients suspected of SOD. However, the high rate of PEP in patients with suspected SOD, despite pancreatic stenting in expert centers, is confirmed in this prospective study. The combined effect of duration of ERCP and sedation type on the development of PEP should be further explored. Clinicaltrials.gov registration: NCT00688662

BACKGROUND AND STUDY AIMS The reason for the increased risk of pancreatitis after endoscopic retrograde cholangiopancreatography (ERCP) in patients with sphincter of Oddi dysfunction is not known. This study sought to determine whether pancreatic sphincter hypertension might explain some of the increased risk. PATIENTS AND METHODS The incidence of pancreatitis was determined from a cohort of patients who underwent pancreatic sphincter manometry. Additional data collected included: pancreatic and biliary sphincter manometry results, distal bile duct diameter, chronic pancreatitis grade by pancreatography, and endoscopic treatments. RESULTS Ten of 32 patients (31%) with pancreatic sphincter hypertension developed post-ERCP pancreatitis, compared to one of 33 (3%) with normal pancreatic manometry (P = 0.002). Patients with pancreatic sphincter hypertension were more likely to undergo endoscopic treatments (88%) compared to those with normal manometry (27%) (P = 0.001). The distal bile duct diameter was significantly smaller (4.5 +/- 0.5 mm) in patients who developed post-ERCP pancreatitis than in those who did not (6.2 +/- 0.3) (P = 0.025). Patients with small distal bile duct diameters (< 5 mm) were three times more likely to develop post-ERCP pancreatitis than those with larger ducts (relative risk [RR] 3.1, 95% confidence interval [CI] 0.9, 10.7). Patients with pancreatic sphincter hypertension were ten times more likely to develop post-ERCP pancreatitis than those with normal pancreatic manometry (RR 10.3, 95% CI 1.5, 76.0). In patients with a small bile duct size, pancreatic sphincter hypertension substantially increased the risk compared to those with normal manometry (RR 18.1, 95% CI 1.1, 287.6). CONCLUSIONS Pancreatic sphincter hypertension greatly increases the risk of post-ERCP pancreatitis in patients undergoing treatment or evaluation, or both, for sphincter of Oddi dysfunction.

Background and study aims Unexplained pancreatitis represents a diagnostic challenge. The aim of this study was to determine the diagnostic utility of endoscopic retrograde cholangiopancreatography (ERCP) with sphincter of Oddi manometry (SOM), bile analysis, and endoscopic ultrasound (EUS) in evaluating such patients. Patients and methods Of 162 patients referred for evaluation of pancreatitis, 72 with a known cause were excluded. The remainder ( n=90) was classified as having prior acute ( n=24) or recurrent acute pancreatitis ( n=66). Bile sampling and SOM were performed at the time of ERCP. EUS was used to assess for tumors and for chronic pancreatitis. Clinical outcomes were evaluated by questionnaire. Results ERCP was successful in 88/89 patients (99 %). Manometry was successful in 63/67 patients (94 %), and 56 patients underwent EUS. Findings were categorized into five distinct etiologies: sphincter of Oddi dysfunction (SOD) ( n=28; 31 %), pancreas divisum ( n=18; 20 %), biliary ( n=18; 20 %), idiopathic ( n=18; 20 %) and tumor-related ( n=8; 9 %). Features of moderate or severe chronic pancreatitis by EUS and ERCP criteria were found in 18 patients (21 %); an additional nine patients had chronic pancreatitis by EUS criteria alone. EUS identified all the tumors. The condition was improved in 96 % of all patients undergoing endoscopic therapy. Conclusion An etiology was identified in the majority of patients with unexplained pancreatitis. SOD represented the most common finding. Moderate to severe chronic pancreatitis was found in over one-fifth of these patients. Bile analysis, SOM, and EUS are useful tools in the evaluation of unexplained acute pancreatitis.