← Back to all trials
Not Yet Recruiting
NCT05720338
Is Intraperitoneal Drainage Necessary Following Distal Pancreatectomy?
Conditions: Cyst of Pancreas, Pancreatectomy, Pancreas Neoplasm
Sex: All
Ages: 18 Years – N/A
Phase: PHASE3
Enrollment: 234
Sponsor: Case Comprehensive Cancer Center
Summary
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.
Eligibility Criteria
Inclusion Criteria:Subjects must be undergoing a scheduled distal pancreatectomy (with or without concurrent splenectomy)Age ≥18 yearsSubjects must have the ability to understand and the willingness to sign a written informed consent document.Exclusion Criteria:Patients < 18 years oldPatients who are pregnantPatients with a history of previous pancreatic surgeryPatients with a history of prior gastric resection, gastric bypass or sleeve gastrectomyPatients with prior cystogastrostomy procedurePatients who have failed prior endoscopic intervention or ultrasound due to esophageal or other gastrointestinal stricturePatients with Type 3 or Type 4 Paraesophageal Hernia noted either on pre-operative imaging or intra-operativelyPatients undergoing concurrent resection of organs other than the pancreas or spleenPatients who undergo oversewing of the pancreatic transection marginPatients with unexpected intraoperative bleeding or adhesive disease which deem it unsafe to proceed without an intraabdominal drainPatients who are unable to provide informed consent
Source: ClinicalTrials.gov (NCT05720338). StuddyBuddy aggregates publicly available trial information.