Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ampulla of Vater Neoplasms | Ampulla of Vater Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Ampullary Adenoma | Ampulla of Vater Adenoma, Intestinal-Type | ALIAS | 0.90 |
| Ampullary Carcinoma | Ampulla of Vater Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Placement of a negative pressure drainage tube | Device | — | UNRESOLVED |
| Placement of a pancreatic duct stent | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Negative Pressure Drainage Group
- description
- Participants undergo endoscopic papillectomy followed by intraoperative placement of a nasally inserted negative-pressure drainage tube positioned distal to the papilla in the descending duodenum. Continuous negative suction is applied to facilitate pancreatic and duodenal drainage.
- interventionNames
- Device: Placement of a negative pressure drainage tube
- type
- ACTIVE_COMPARATOR
- label
- Pancreatic Duct Stenting Group
- description
- Participants undergo endoscopic papillectomy followed by prophylactic placement of a plastic pancreatic duct stent under endoscopic and fluoroscopic guidance to promote pancreatic drainage and reduce the risk of postoperative pancreatitis.
- interventionNames
- Procedure: Placement of a pancreatic duct stent
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age between 18 and 75 years 2. Preoperative diagnosis of duodenal papillary adenoma or early-stage adenocarcinoma (≤T1a) 3. Scheduled to undergo endoscopic papillectomy Exclusion Criteria: 1. Preoperative diagnosis suggestive of adenocarcinoma ≥T1b stage. 2. Preoperative imaging indicating intraductal extension into the pancreatic or bile duct ≥20 mm. 3. Lesion diameter \>40 mm, location adjacent to a duodenal diverticulum, or other anatomical or technical factors deemed unsuitable for endoscopic resection. 4. Known familial adenomatous polyposis (FAP). 5. Severe cardiopulmonary disease precluding tolerance of anesthesia or endoscopic procedures. 6. Coagulopathy or bleeding disorders. 7. Pregnancy or lactation.
References
Publications (0)
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