Pharmacological prophylaxis versus pancreatic duct stenting plus pharmacological prophylaxis for prevention of post-ERCP pancreatitis in high risk patients: a randomized trial

Background Acute pancreatitis is a serious complication of endoscopic retrograde cholangiopancreatography (ERCP). The aim of this noninferiority study was to evaluate the effectiveness of pancreatic duct (PD) stenting plus pharmacological prophylaxis vs. pharmacological prophylaxis alone in the prevention of post-ERCP pancreatitis (PEP) in high risk patients. Methods In this randomized, controlled, double-blind, noninferiority trial, patients at high risk of developing PEP were randomly allocated to pharmacological prophylaxis (rectal indomethacin, sublingual isosorbide dinitrate, and intravenous hydration with Ringer's lactate) plus PD stenting (group A) or pharmacological prophylaxis alone (group B). The rate and severity of PEP, serum amylase levels, and length of hospital stay after ERCP were assessed. Results During 21 months, a total of 414 patients (mean age 55.517.0 years; 60.2% female) were enrolled (207 in each group). PEP occurred in 59 patients (14.3%, 95% confidence interval [CI] 11.1%-17.9%: 26 patients [12.6%, 95%CI 8.6%-17.6%] in group A and 33 [15.9%, 95%CI 11.4%-21.4%] in group B). There was no significant difference between the two groups in PEP severity (P=0.59), amylase levels after 2 hours (P=0.31) or 24 hours (P=0.08), and length of hospital stay (P=0.07). Conclusions The study failed to demonstrate noninferiority or inferiority of pharmacological prophylaxis alone compared with PD stenting plus pharmacological prophylaxis in the prevention of PEP in high risk patients.