This prospective, multicenter, randomized controlled trial aims to evaluate the effectiveness of negative-pressure duodenal drainage compared with prophylactic pancreatic duct stenting in preventing post-endoscopic papillectomy (EP) pancreatitis. Eligible patients undergoing EP will be randomized 1:1 to receive either negative-pressure drainage or pancreatic duct stenting. The primary outcome is the incidence of post-EP pancreatitis. Secondary outcomes include other procedure-related complications, procedure time, technical success, length of hospital stay, hospitalization cost, en-bloc and R0 resection rates, and postoperative hyperamylasemia.
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Incidence of post-endoscopic papillectomy pancreatitis
Timeframe: Postoperative days 1, 2, and 3 (assessed daily); from postoperative day 4 through hospital discharge from the index hospitalization, assessed as clinically indicated (when pancreatitis is suspected)