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Is Intraperitoneal Drainage Necessary Following Distal Pancreatectomy?

NCT05720338 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 234

Last updated 2026-02-19

No results posted yet for this study

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.

Conditions

  • Cyst of Pancreas
  • Pancreatectomy
  • Pancreas Neoplasm

Interventions

DEVICE

19 French Blake Drain

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

Sponsors & Collaborators

  • Case Comprehensive Cancer Center

    lead OTHER

Principal Investigators

  • Robert Simon, MD · Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-13
Primary Completion
2026-12-31
Completion
2027-07-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05720338 on ClinicalTrials.gov