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).
Parallel
Placement of a negative pressure drainage tube
DeviceA flexible polymer drainage tube is inserted transnasally immediately after endoscopic papillectomy and advanced so that the tip rests distal to the papilla in the descending duodenum. The external end is connected to a manual suction device to provide continuous negative pressure and promote evacuation of pancreatic secretions and duodenal contents. The tube is monitored for function, displacement, and blockage and is removed approximately 72 hours postprocedure if no significant complications occur. Rescue therapy: in the event of significant intraoperative bleeding, perforation, or other device-related complications, a pancreatic duct stent may be placed while maintaining the negative-pressure tube for continued drainage.
Placement of a pancreatic duct stent
Procedure/SurgeryA plastic pancreatic duct stent is placed under endoscopic and fluoroscopic guidance immediately after endoscopic papillectomy to facilitate pancreatic drainage and reduce the risk of postoperative pancreatitis. Stent diameter and length are selected by the endoscopist based on intraoperative findings and preoperative imaging. If stent placement fails after three or more attempts or cumulative placement time exceeds 15 minutes, the procedure is considered unsuccessful and a nasally inserted negative-pressure drainage tube will be used as rescue therapy. Successfully placed stents are scheduled for endoscopic removal within 30 days.
Incidence of post-endoscopic papillectomy pancreatitis
Diagnosis will be based on the revised Atlanta classification, incorporating clinical symptoms (abdominal pain), laboratory findings (serum amylase or lipase ≥3 times the upper limit of normal), and imaging evidence (CT or MRI indicating pancreatitis). Daily assessment and documentation will be performed by study physicians.
R0 resection rate (complete resection)
R0 resection will be determined based on the pathology report, defined as histologically negative resection margins. Final assessment will be made by the pathologist.
Technical success rate of intended drainage placement
Defined as successful completion of the initially assigned drainage method (negative pressure drainage or pancreatic duct stenting) without intraoperative crossover. For pancreatic duct stenting, technical success requires successful pancreatic duct cannulation and stent deployment. For negative pressure drainage, technical success requires successful placement of the drainage tube at the intended duodenal position with effective negative pressure suction. Determined and recorded by the endoscopist during the procedure.
Incidence of hyperamylasemia
Serum amylase levels will be measured at scheduled postoperative timepoints. Hyperamylasemia is defined as an elevation above the upper limit of normal in the absence of clinical signs of pancreatitis. Diagnosis is based on laboratory results and recorded in the case report form (CRF).
Length of hospital stay
Length of hospital stay will be calculated from the date of admission to the date of discharge, measured in days and extracted from the hospital medical record system.
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Cui Xiaobing
Lead sponsor
Shenzhen Hospital of Southern Medical University
Sponsor institution
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