NCT07446543Not yet recruiting
Effect of Negative-Pressure Drainage Versus Pancreatic Duct Stenting for Preventing Pancreatitis After Endoscopic Papillectomy for Duodenal Papillary Tumors
Effect of Negative-Pressure Drainage Versus Pancreatic Duct Stenting for Preventing Pancreatitis After Endoscopic Papillectomy for Duodenal Papillary Tumors: A Prospective, Multicenter, Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 4 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 132 (estimated)
- First submitted
- 6 Jan 2026
- Start date
- Mar 2026
- Primary completion date
- Jun 2029
- Lead sponsor
- Cui Xiaobing
- Diseases
- Pancreatic cancer
- NCT number
- NCT07446543
What you commit to
- Study type: Interventional
- Planned participants: 132
- From Mar 2026 to the primary completion date, Jun 2029
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Lesion diameter \>40 mm, location adjacent to a duodenal diverticulum, or other anatomical or technical factors deemed unsuitable for endoscopic resection.
Other illness
- Severe cardiopulmonary disease precluding tolerance of anesthesia or endoscopic procedures.
- Coagulopathy or bleeding disorders.
Other
- Preoperative diagnosis suggestive of adenocarcinoma ≥T1b stage.
- Preoperative imaging indicating intraductal extension into the pancreatic or bile duct ≥20 mm.
- Known familial adenomatous polyposis (FAP).
- Pregnancy or lactation.
Who the study is looking for
- Age between 18 and 75 years
- Preoperative diagnosis of duodenal papillary adenoma or early-stage adenocarcinoma (≤T1a)
- Scheduled to undergo endoscopic papillectomy
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.