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Biliary Plus Pancreatic Stent vs Pancreatic Stent Alone After Endoscopic Papillectomy
Sponsor: Qilu Hospital of Shandong University
Summary
This is a prospective, multicenter, open-label, randomized controlled trial designed to evaluate the safety and efficacy of biliary stent placement combined with pancreatic stent placement versus pancreatic stent alone in patients undergoing endoscopic papillectomy (EP) for duodenal ampullary adenoma. The primary objective is to compare the overall incidence of post-procedural complications between the two groups. A total of 190 patients will be enrolled and randomized 1:1 to receive either pancreatic stent alone (PS group) or combined biliary and pancreatic stents (PBS group).
Official title: Biliary Stent Combined With Pancreatic Stent Versus Pancreatic Stent Alone in Endoscopic Papillectomy for Duodenal Ampullary Adenoma: A Multicenter, Randomized Controlled Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
190
Start Date
2026-10-20
Completion Date
2029-04-20
Last Updated
2026-10-23
Healthy Volunteers
No
Conditions
Interventions
Endoscopic papillectomy with pancreatic duct stent placement
Patients undergo standard EP for duodenal ampullary adenoma. A pancreatic duct stent is placed at the end of the procedure; no biliary stent is placed.
Endoscopic papillectomy with pancreatic duct and biliary stent placement
Patients undergo standard EP for duodenal ampullary adenoma. Both prophylactic pancreatic duct and biliary stents are placed at the end of the procedure.
Locations (1)
Qilu Hospital of Shandong University
Jinan, Shandong, China