Clinical trial · Interventional
Post-operative Drainage After Pancreaticoduodenectomy
Post-operative Drainage After Pancreaticoduodenectomy: A Randomized Controlled Trial of Patients With Intermediate and Low Risk for Pancreatic Fistula
NCT05270564CI-TRIAL-00056951Drain 1unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
The study compares regular use of surgical drains and no use of surgical drains in patients subjected to pancreaticoduodenectomy with expected low to intermediate risk for post operative pancreatic fistula.
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 |
|---|---|---|---|
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Drain | Procedure | — | UNRESOLVED |
| No drain | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Drain
- description
- Surgical drains used as routine
- interventionNames
- Procedure: Drain
- type
- EXPERIMENTAL
- label
- No drain
- description
- No surgical drain used
- interventionNames
- Procedure: No drain
Primary outcomes (1)
- measure
- Overall morbidity rate
- timeFrame
- 90 days post operatively
- description
- Post operative morbidity
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients undergoing pancreaticoduodenectomy of both sexes * Patients with predicted risk score of 10 or less of pancreatic fistula * Written informed consent * Expected survival time \> 6 months Exclusion Criteria: * Patients with predicted high risk of fistula with a risk score above 10 * Patients with intraabdominal abscess or infection * ASA score \> 3 * Pregnancy * Expected lack of compliance
References
Publications (1)
- DERIVEDWallon S, Williamsson C, Karlsson V, Wennerblom J, Bratlie SO, Sandstrom P, Tingstedt B, Bjornsson B. Postoperative drainage after pancreatoduodenectomy: a randomized controlled trial among patients with intermediate and low risks for pancreatic fistula-DRAIN1. Trials. 2026 May 5;27(1):357. doi: 10.1186/s13063-026-09762-9. PMID 42083018