Effect of Negative-Pressure Drainage Versus Pancreatic Duct Stenting for Preventing Pancreatitis After Endoscopic Papillectomy for Duodenal Papillary Tumors
Starting soon · Not applicable
Conditions studied: Ampulla of Vater Neoplasms, Ampullary Adenoma, Ampullary Carcinoma
In brief
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.
Key facts
- Study ID
- NCT07446543
- Run by
- Cui Xiaobing
- People needed
- 132
- Starts
- 2026-03-20
- Expected to finish
- 2029-06-30
- Last updated by the study team
- 2026-03-04
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age between 18 and 75 years
- Preoperative diagnosis of duodenal papillary adenoma or early-stage adenocarcinoma (≤T1a)
- Scheduled to undergo endoscopic papillectomy
You may not qualify if…
- 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).
- Severe cardiopulmonary disease precluding tolerance of anesthesia or endoscopic procedures.
- Coagulopathy or bleeding disorders.
- Pregnancy or lactation.
Full record on ClinicalTrials.gov
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