Clinical trial · Interventional
Pancreas Resection With and Without Drains
A Randomized Prospective Multicenter Trial of Pancreas Resection With and Without Routine Intraperitoneal Drainage
NCT01441492CI-TRIAL-00046863completedN/AResults postedClinicalTrials.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)
This randomized prospective trial is designed to test the hypothesis that pancreatectomy without routine intraperitoneal drainage does not increase the severity or frequency of complications within 60 days of surgery.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreas Tumor | Pancreatic Neoplasm | ALIAS | 0.90 |
| Pancreatitis | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Drains | Procedure | — | UNRESOLVED |
| No Drains | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- No Drains
- description
- Patients who will not receive intraperitoneal drainage following pancreas resection.
- interventionNames
- Procedure: No Drains
- type
- EXPERIMENTAL
- label
- Drains
- description
- Patients who will receive drains, the standard of care treatment, following pancreas resection.
- interventionNames
- Procedure: Drains
Primary outcomes (1)
- measure
- 60-day ≥ Grade II Complication Rate
- timeFrame
- 60 days
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * The subject has a surgical indication for distal pancreatectomy. * In the opinion of the surgeon, the subject has no medical contraindications to pancreatectomy. * At least 18 years of age. * The subject is willing to consent to randomization to the intraperitoneal drain vs. no drain group. * The subject is willing to comply with 90-day follow-up and answer quality-of-life questionnaires per protocol. Exclusion Criteria: * The subject does not have a surgical indication for distal pancreatectomy. * In the opinion of the surgeon, the subject has medical contraindications to pancreatectomy. * Less than 18 years of age. * The subject is not willing to consent to randomization to the intraperitoneal drain vs. no drain group. * The subject is not willing to comply with 90-day follow-up and answer quality-of-life questionnaires per protocol.
References
Publications (2)
- BACKGROUNDFisher WE, Hodges SE, Silberfein EJ, Artinyan A, Ahern CH, Jo E, Brunicardi FC. Pancreatic resection without routine intraperitoneal drainage. HPB (Oxford). 2011 Jul;13(7):503-10. doi: 10.1111/j.1477-2574.2011.00331.x. PMID 21689234
- BACKGROUNDVan Buren G 2nd, Bloomston M, Hughes SJ, Winter J, Behrman SW, Zyromski NJ, Vollmer C, Velanovich V, Riall T, Muscarella P, Trevino J, Nakeeb A, Schmidt CM, Behrns K, Ellison EC, Barakat O, Perry KA, Drebin J, House M, Abdel-Misih S, Silberfein EJ, Goldin S, Brown K, Mohammed S, Hodges SE, McElhany A, Issazadeh M, Jo E, Mo Q, Fisher WE. A randomized prospective multicenter trial of pancreaticoduodenectomy with and without routine intraperitoneal drainage. Ann Surg. 2014 Apr;259(4):605-12. doi: 10.1097/SLA.0000000000000460. PMID 24374513