Biliary Plus Pancreatic Stent vs Pancreatic Stent Alone After Endoscopic Papillectomy

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).

Inclusion Criteria: 1. Age ≥18 years. 2. Patients with histologically confirmed duodenal papillary adenoma or early-stage adenocarcinoma (≤T1a) 3. Scheduled to undergo endoscopic papillectomy (EP). 4. Patients confirmed by endoscopic ultrasound (EUS), magnetic resonance cholangiopancreatography (MRCP) or Intraductal ultrasound (IDUS )indicating no intraductal extension into the pancreatic or bile duct. 5. Patients who provide written informed consent. Exclusion Criteria: 1. Contraindications to endoscopic procedures (e.g., severe esophageal stricture, inability to tolerate sedation). 2. Ectopic duodenal papilla or congenital pancreaticobiliary developmental anomalies (e.g., pancreaticobiliary maljunction, pancreas divisum) . 3. Pregnant or lactating women. 4. Uncorrectable coagulopathy (INR \> 1.5) or thrombocytopenia (platelet count \< 50,000/μL), or inability to withhold antithrombotic (anticoagulant or antiplatelet) therapy for the planned endoscopic procedure. 5. Major upper abdominal surgery or previous biliary surgery history.