Background & Aims: The role of sphincter of Oddi manometry (SOM) in the management of patients with idiopathic recurrent acute pancreatitis requires clarification. We evaluated the therapeutic effects of endoscopic sphincterotomy in patients with recurrent acute pancreatitis and the prognostic significance of pancreatic sphincter dysfunction (SOD). Methods: We performed a randomized trial of endoscopic retrograde cholangiopancreatography with SOM for patients with idiopathic recurrent acute pancreatitis. Patients with pancreatic SOD (n = 69) were assigned randomly to groups that received only biliary sphincterotomy (BES) or a combination of biliary and pancreatic sphincterotomy (DES); patients who underwent normal SOM (n = 20) were assigned randomly to groups that received BES or a sham surgery. The primary outcome was incidence of recurrent acute pancreatitis during the follow-up period (minimum, 1 year; maximum, 10 years). We also determined the incidence of chronic pancreatitis and analyzed factors associated with recurrence of acute pancreatitis. Results: Among the 69 patients with SOD, 48.5% who received BES and 47.2% who received DES had recurrent acute pancreatitis (95% confidence interval, -22.3 to 24.9; P = 1.0). In patients with normal SOM (n = 20), 27.3% of those who received BES and 11.1% of those who received the sham surgery had recurrent acute pancreatitis (95% confidence interval, -49.5 to 17.2; P =.59). Overall, 16.9% of subjects developed chronic pancreatitis during a median follow-up period of 78 months (interquartile range, 35-108 mo). The odds of recurrent acute pancreatitis during follow-up evaluation were significantly greater among patients with SOD than those with normal SOM (unadjusted hazard ratio, 3.5; 95% confidence interval, 1.07-11.4; P <.04), and remained so after adjusting for potential confounders (hazard ratio, 4.3; 95% confidence interval, 1.3-14.5; P <.02). Conclusions: Among patients with pancreatic SOD, DES and BES have similar effects in preventing recurrence of acute pancreatitis. Pancreatic SOD is an independent prognostic factor, identifying patients at higher risk for recurrent acute pancreatitis. Clinical Trials Registration: Clinicaltrials.gov (NCT01583517).
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