RecruitingNot ApplicableNCT05992857

Pancreaticoduodenectomies With Complete Arterial Coverage by Retromesenteric Omentoplasty

Randomized Controlled Trial Comparing Pancreaticoduodenectomies With or Without Complete Arterial Coverage by Omentoplasty in Patients With High Risk of Postoperative Pancreatic Fistula.

Sponsor

Assistance Publique - Hôpitaux de Paris

Enrollment

150 participants

Start Date

Oct 22, 2024

Study Type

INTERVENTIONAL

Conditions

Complication of Surgical Procedure Pancreatectomy

Summary

To assess the efficacy of complete covering using retromesenteric omentoplasty vs. partial covering or no covering of peripancreatic arteries in decreasing incidence of grade B+C post-pancreatectomy hemorrhage (PPH), i.e. treated by transfusion and / or radiological or surgical hemostasis after PD in patients with high risk of POPF.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating a surgical technique that wraps fatty tissue (called the omentum) around the arteries during pancreatic surgery (a Whipple procedure) to reduce the risk of a dangerous complication called post-operative bleeding from artery erosion. **You may be eligible if...** - You are 18 years or older - You are scheduled for a pancreaticoduodenectomy (Whipple procedure) — a surgery to remove part of the pancreas, small intestine, and bile duct - Your surgery is done via an open approach (not laparoscopic) - Your intraoperative fistula risk score is 7 or higher - You are covered by French public health insurance **You may NOT be eligible if...** - Your surgery is done laparoscopically (minimally invasive) - You do not meet the required risk score - You are unable to give informed consent 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

PROCEDUREPancreaticoduodenectomy without retromesenteric omental flap

Resection of the pancreatic head, duodenum, distal common bile duct and gallbladder followed by reconstruction using pancreaticojejunostomy, hepaticojejunostomy, and gastrojejunostomy performed on the first jejunal loop.

PROCEDUREPancreaticoduodenectomy with retromesenteric omental flap

All exposed peripancratic arteries should be covered with a retromesentric omental flap

Locations(1)

Beaujon Hospital

Clichy, France

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NCT05992857

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