Clinical trial · Interventional
Prophylactic Pancreatic Duct Stent Placement After ESP of Major Papillary Tumors; Prospective, Randomized Study
Prophylactic Pancreatic Duct Stent Placement After Endoscopic Snare Papillectomy of Duodenal Major Papillary Tumors; Prospective, Randomized, Controlled Study
- 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)
Endoscopic snare papillectomy (ESP) is an efficient treatment for benign tumors of the duodenal major papilla. But post-ESP pancreatitis is the most common and serious complication. Since one prospective randomized controlled trial showed that pancreatic duct stent placement reduced post-ESP pancreatitis, almost physicians have tried to place the pancreatic duct stent after EPS. The aim of this prospective, randomized, multicenter trial is to compare the rates of post-ESP pancreatitis in patients who did or did not prophylactic pancreatic duct stent placement. Consecutive patients who were to undergo ESP were to randomized to pancreatic duct stent placement group (stent group) after endoscopic snare papillectomy or to no pancreatic duct stent placement group (no stent group).
Conditions
Conditions (1)
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 Adenoma | Ampulla of Vater Adenoma, Intestinal-Type | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Endoscopic snare papillectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Group A
- description
- Endoscopic snare papillectomy (ESP) was performed by using diagnostic or therapeutic duodenoscope (JF-240, TJF-240, JF-260, TJF-260; Olympus Optical Co, Ltd, Tokyo, Japan). A pancreatic duct stent was inserted immediately after the excision.
- interventionNames
- Procedure: Endoscopic snare papillectomy
- type
- ACTIVE_COMPARATOR
- label
- Group B
- description
- Endoscopic snare papillectomy (ESP) was performed by using diagnostic or therapeutic duodenoscope (JF-240, TJF-240, JF-260, TJF-260; Olympus Optical Co, Ltd, Tokyo, Japan). A pancreatic duct stent was not inserted immediately after the excision.
- interventionNames
- Procedure: Endoscopic snare papillectomy
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Age: 20 to 80 years, Histopathologically proven ampullary adenoma Exclusion Criteria: * Lesions with irregular margin, ulceration and spontaneous or easy to bleeding which presenting malignancy. * Extensive lesion into PD or BD on ERCP, EUS or IDUS. * Tumor size \> 4cm * Bleeding tendency
References
Publications (0)
Data not yet available