Prospective, randomized, controlled trial of prophylactic pancreatic stent placement for endoscopic snare excision of the duodenal ampulla

Background: Tumors that arise in the region of the major duodenal papilla account for 5% of GI neoplasms and 36% of resectable pancreaticoduodenal tumors. There is limited published literature that addresses the safety of endoscopic excision of the papilla. Although there is consensus about prophylactic pancreatic-duct stent placement, there is little supporting prospective data. The aim of this randomized, controlled trial was to compare the rates of postsnare ampullectomy pancreatitis in patients who did/did not receive prophylactic pancreatic-duct stent placement. Methods: Consecutive patients who were to undergo en bloc snare ampullectomy were randomized to placement of pancreatic-duct stent after ampullectomy or to no stent placement. Results: In total, 19 patients were enrolled, and 10 received pancreatic stents. Postprocedure pancreatitis occurred in 3 patients in the 24 hours after endoscopy, all cases occurred in the unstented group, 33% vs. 0% (stented group), p = 0.02. Median peak amylase level was 3692 U/L (range 1819-4700 U/L) and median peak lipase level was 11450 U/L (range 5900-17,000 U/L). All 3 patients were hospitalized for a median of 2 days (range 1-6), and all made a complete recovery. Conclusions: Our findings suggest that a protective effect is conferred by pancreatic stent placement in reducing postampullectomy pancreatitis. Future large-scale studies are required to confirm this benefit.