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Is Intraperitoneal Drainage Necessary Following Distal Pancreatectomy?
Is Intraperitoneal Drainage Necessary Following Distal Pancreatectomy: A Randomized Control Trial
Who can join
Ages 18 and older · All sexes
Full 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
About the study
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.
What is being tested
- 19 French Blake Drain (device)
Sponsor: Case Comprehensive Cancer Center · Participants: 234 · Started: Apr 13, 2023
Contact the study team
- Robert Simon, MD · Phone: 1-866-223-8100
Official record on ClinicalTrials.gov — NCT05720338
Locations in the U.S.
| Ohio | Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center, Cleveland |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.