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

What this Trial Is About

This research aims to evaluate the effectiveness of fully covering peripancreatic arteries using a retromesenteric omentoplasty compared to partial or no coverage in reducing serious bleeding complications after pancreaticoduodenectomy (PD) in patients at high risk of postoperative pancreatic fistula (POPF). The study focuses on preventing grade B and C postpancreatectomy hemorrhage (PPH), a severe complication following PD, especially in patients with a high fistula risk score between 7 and 10. This trial is a randomized controlled trial coordinated by Assistance Publique - Hôpitaux de Paris. Participants will undergo PD surgery and be randomly assigned during the operation to either receive a J-shaped omental flap covering all peri-pancreatic arteries at risk of bleeding or to a control group where no such flap or only partial coverage is applied. The omental flap is created by mobilizing the greater omentum and passing it through the retromesenteric route to protect arteries like the hepatic artery and superior mesenteric artery. The control group receives standard care without complete arterial coverage by omentoplasty. Participants will be followed through several visits: an initial selection visit before surgery, an end-of-hospitalization visit, a follow-up at 45 days post-operation, and a final visit at 90 days post-operation. Additional visits may occur if complications arise. During these visits, data on bleeding events, mortality, complications, pancreatic fistula rates, hospital readmissions, and arterial pseudoaneurysms will be collected to evaluate the study's outcomes and safety.

Pancreaticoduodenectomies With Complete Arterial Coverage by Retromesenteric Omentoplasty