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.
Age between 18 and 75 years
Preoperative diagnosis of duodenal papillary adenoma or early-stage adenocarcinoma (≤T1a)
Scheduled to undergo endoscopic papillectomy
Preoperative diagnosis suggestive of adenocarcinoma ≥T1b stage.
Preoperative imaging indicating intraductal extension into the pancreatic or bile duct ≥20 mm.
Lesion diameter >40 mm, location adjacent to a duodenal diverticulum, or other anatomical or technical factors deemed unsuitable for endoscopic resection.
Known familial adenomatous polyposis (FAP).
Cui Xiaobing
Lead sponsor
Shenzhen Hospital of Southern Medical University
Sponsor institution