Optimal Retention Duration of Prophylactic Pancreatic Duct Stents Placed During Endoscopic Retrograde Cholangiopancreatography: A Multicenter Randomized Controlled Trial

초록

Background & aims: Prophylactic pancreatic duct stent placement is used during endoscopic retrograde cholangiopancreatography to prevent post-endoscopic retrograde cholangiopancreatography pancreatitis and facilitate difficult biliary cannulation; however, the optimal retention duration of prophylactic pancreatic duct stent remains uncertain. This trial compared 2-week vs 4-week pancreatic duct stent retention to determine the strategy that minimizes the need for endoscopic stent removal without compromising safety. Methods: In this prospective multicenter trial, adults undergoing endoscopic retrograde cholangiopancreatography with placement of a 5-Fr single-pigtail unflanged pancreatic duct stent were randomized in a 1:1 ratio to undergo scheduled assessment at 2 or 4 weeks post-endoscopic retrograde cholangiopancreatography to evaluate pancreatic duct stent retention via abdominal radiography. The primary outcome was the proportion of patients requiring endoscopic stent removal due to confirmed pancreatic duct stent retention. Secondary outcomes included spontaneous stent dislodgment, incidence and severity of post endoscopic retrograde cholangiopancreatography pancreatitis and pancreatic duct stent-associated pancreatitis, and length of hospital stay. Results: Among 182 screened patients, 160 were randomized, and 156 were analyzed (80 in the 2-week group; 76 in the 4-week group). The primary outcome, requirement for endoscopic pancreatic duct stent removal, was significantly lower in the 4-week group than in the 2-week group (6.6% [5/76] vs 18.8% [15/80]; odds ratio, 0.305; 95% confidence interval, 0.105-0.887; P = .030). This was driven by a higher spontaneous dislodgment rate in the 4-week group (92.1% [70/76] vs 81.3% [65/80]; odds ratio, 0.371; 95% confidence interval, 0.136-1.015; P = .061). Post-endoscopic retrograde cholangiopancreatography pancreatitis developed in 10.5% (8/76) of the 4-week group and 15.0% (12/80) of the 2-week group (P = .403), with a median onset of 1 day post-endoscopic retrograde cholangiopancreatography. Post-endoscopic retrograde cholangiopancreatography pancreatitis was predominantly mild, with only 2 moderate cases in each group. No cases of pancreatic duct stent-associated pancreatitis were observed during the study period. Conclusions: A 4-week retention strategy reduced the need for endoscopic stent removal without increasing the incidence of post-endoscopic retrograde cholangiopancreatography pancreatitis or other clinically relevant complications.

키워드