Clinical trial · Interventional
Is Intraperitoneal Drainage Necessary Following Distal Pancreatectomy?
Is Intraperitoneal Drainage Necessary Following Distal Pancreatectomy: A Randomized Control Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 16, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260916-000001
Summary
Brief summary (as posted)
The goal of this clinical trial is to analyze if intraperitoneal drainage is necessary following distal pancreatectomy. This study aims to determine whether the omission of routine intraperitoneal drainage in the setting of reinforced staple technology is non-inferior to routine intraperitoneal drainage with respect to a composite post-operative complications of Grade B or C Postoperative pancreatic fistula (POPF), readmission, or organ space surgical site infection following a distal pancreatectomy.
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 |
|---|---|---|---|
| Cyst of Pancreas | — | UNRESOLVED | — |
| Pancreas Neoplasm | Pancreatic Neoplasm | ALIAS | 0.90 |
| Pancreatectomy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 19 French Blake Drain | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Standard of care
- description
- Intraperitoneal drain will be placed near the pancreatic resection margin, which is the routine standard of care.
- interventionNames
- Device: 19 French Blake Drain
- type
- NO_INTERVENTION
- label
- Omitting Standard of Care
- description
- No intraperitoneal drain will be placed in the participants, which omits the routine standard of care.
Primary outcomes (4)
- measure
- Composite endpoint comparison
- timeFrame
- Within 90 days of surgery
- description
- Comparison between groups using a composite endpoint of complications that includes presence of Grade B POPF
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Subjects must be undergoing a scheduled distal pancreatectomy (with or without concurrent splenectomy) * Age ≥18 years * Subjects must have the ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: * Patients \< 18 years old * Patients who are pregnant * Patients with a history of previous pancreatic surgery * Patients with a history of prior gastric resection, gastric bypass or sleeve gastrectomy * Patients with prior cystogastrostomy procedure * Patients who have failed prior endoscopic intervention or ultrasound due to esophageal or other gastrointestinal stricture * Patients with Type 3 or Type 4 Paraesophageal Hernia noted either on pre-operative imaging or intra-operatively * Patients undergoing concurrent resection of organs other than the pancreas or spleen or gallbladder * Patients who undergo oversewing of the pancreatic transection margin * Patients with unexpected intraoperative bleeding or adhesive disease which deem it unsafe to proceed without an intraabdominal drain * Patients who are unable to provide informed consent
References
Publications (0)
Data not yet available