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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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05720338). StuddyBuddy aggregates publicly available trial information.