Clinical Trial

Effect of Negative-Pressure Drainage Versus Pancreatic Duct Stenting for Preventing Pancreatitis After Endoscopic Papillectomy for Duodenal Papillary Tumors

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Summary
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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2026-02-28.
Trial Details
NCT Number NCT07446543
Lead Sponsor Cui Xiaobing
Conditions Ampulla of Vater Neoplasms, Ampullary Adenoma, Ampullary Carcinoma
Enrollment 132 participants
Start Date 2026-03-20
Primary Completion 2029-06-30 (estimated)
Study Completion 2029-06-30 (estimated)
Updated on ClinicalTrials.gov 2026-03-04