RECRUITING Phase 3 ClinicalTrials.gov

Is Intraperitoneal Drainage Necessary Following Distal Pancreatectomy?

Sponsor: Case Comprehensive Cancer Center • ClinicalTrials.gov ID: NCT05720338

Registry updated: 2026-09-15

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Description

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.

Interventions

19 French Blake Drain (Device)
19 French Blake Intraperitoneal Drain will be placed near the pancreatic resection margin

Eligibility criteria

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

Conditions

Cyst of Pancreas Pancreatectomy Pancreas Neoplasm

Locations

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center — Cleveland, Ohio, United States

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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