RecruitingPhase 3NCT05720338

Is Intraperitoneal Drainage Necessary Following Distal Pancreatectomy?

Is Intraperitoneal Drainage Necessary Following Distal Pancreatectomy: A Randomized Control Trial


Sponsor

Case Comprehensive Cancer Center

Enrollment

234 participants

Start Date

Apr 13, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether it is safe to skip placing an abdominal drain (a tube placed inside the abdomen at the end of surgery to collect fluid) after distal pancreatectomy — a surgery that removes the left side of the pancreas. The standard practice includes a drain, but researchers want to know if patients do just as well without one. **You may be eligible if...** - You are 18 or older - You are scheduled for a planned distal pancreatectomy (with or without spleen removal) - You understand and are willing to consent to participation **You may NOT be eligible if...** - You are under 18 years old - You are pregnant - You have previously had pancreatic surgery, gastric surgery (bypass, sleeve, or resection), or a cystogastrostomy procedure - Unexpected major bleeding or serious complications arise during surgery that the surgeon feels require a drain for safety Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICE19 French Blake Drain

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


Locations(1)

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Cleveland, Ohio, United States

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NCT05720338


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