BACKGROUND & AIMS: Pancreatitis after endoscopic retrograde cholangiopancreatography (ERCP) is the most common and potentially serious complication of ERCP. The frequency of post-ERCP pancreatitis generally is reported to be between 1% and 9%. One cause of pancreatitis is retention of pancreatic juice resulting from papilledema after the procedure. We conducted a randomized controlled multicenter study to evaluate whether placement of a temporary pancreatic stent designed for spontaneous dislodgement prevents post-ERCP pancreatitis. METHODS: The subjects were 201 consecutive patients who underwentERCP. The patients were randomized into the stent placement group (S group = 98) or the nonstent placement group (nS group = 103). The stent used was 5F in diameter, 3 cm in length, straight, and unflanged inside. RESULTS: Stents were placed successfully in 96% of the S group, and spontaneous stent dislodgment was recognized in 95.7% of those. The mean duration to dislodgment was 2 days, and there were no severe complications. The overall frequency of post-ERCP pancreatitis was 8.5%. The frequency of post-ERCP pancreatitis in the S and nS groups was 3.2% and 13.6%, respectively, showing a significantly lower frequency in the S group (P = .019). The mean increase in amylase level in the pancreatitis patients was significantly higher in the nS group (P = .014). CONCLUSIONS: The randomized controlled multicenter trial showed that placement of a pancreatic spontaneous dislodgment stent significantly reduces post-ERCP pancreatitis.
RCT Entities:
BACKGROUND & AIMS:Pancreatitis after endoscopic retrograde cholangiopancreatography (ERCP) is the most common and potentially serious complication of ERCP. The frequency of post-ERCP pancreatitis generally is reported to be between 1% and 9%. One cause of pancreatitis is retention of pancreatic juice resulting from papilledema after the procedure. We conducted a randomized controlled multicenter study to evaluate whether placement of a temporary pancreatic stent designed for spontaneous dislodgement prevents post-ERCP pancreatitis. METHODS: The subjects were 201 consecutive patients who underwent ERCP. The patients were randomized into the stent placement group (S group = 98) or the nonstent placement group (nS group = 103). The stent used was 5F in diameter, 3 cm in length, straight, and unflanged inside. RESULTS: Stents were placed successfully in 96% of the S group, and spontaneous stent dislodgment was recognized in 95.7% of those. The mean duration to dislodgment was 2 days, and there were no severe complications. The overall frequency of post-ERCP pancreatitis was 8.5%. The frequency of post-ERCP pancreatitis in the S and nS groups was 3.2% and 13.6%, respectively, showing a significantly lower frequency in the S group (P = .019). The mean increase in amylase level in the pancreatitispatients was significantly higher in the nS group (P = .014). CONCLUSIONS: The randomized controlled multicenter trial showed that placement of a pancreatic spontaneous dislodgment stent significantly reduces post-ERCP pancreatitis.