PAncreaticoduodenectomies With COMplete ARterial Coverage by Retromesenteric Omentoplasty (PACOMARCO)
Pancreatectomy, Complication of Surgical Procedure
About this trial
This is an interventional treatment trial for Pancreatectomy focused on measuring Pancreaticoduodenectomy, Post-pancreatectomy haemorrhage, Omentoplasty, Post-operative pancreatic fistula
Eligibility Criteria
Inclusion Criteria: Age ≥ 18 years Patients requiring a pancreaticoduodenectomy (PD) for any indication Open approach Affiliation to the French public healthcare insurance Fistula risk score (FRS) ≥ 7 confirmed intraoperatively Ability to understand and to comply with the study protocol Reconstruction with PJ and external pancreatic stent Signed written informed consent Inclusion is allowed for patients: On curative or long-term anticoagulation or aspirin (indicated for previous thromboembolic complications, heart disease, previous history of stroke) Undergoing PD with venous resection Exclusion Criteria: Presence of distant tumor deposits (liver and peritoneal metastases, and/or para-aortic lymph nodes metastases) reveals during intraoperative exploration for patient with malignant pancreatic or periampullary tumor. Patients with previous abdominal surgery compromising completion of retromesenteric omentoplasty PD with arterial resection (i.e. resection of hepatic artery, splenic artery, superior mesenteric artery, or celiac axis) Laparoscopic or robotic PD Reconstruction wih pancreatico-gastrostomy Total pancreatectomy Emergency procedure Pregnant women Patient under guardianship and curatorship Participation in another interventional study evaluating complication after pancreaticoduodenectomy or patient still being in the exclusion period at the end of a previous study evaluating drugs.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Retromesenteric omental flap covering all exposed peripancreatic arteries
Control
A J-shaped omental flap is created by extensive mobilization of the greater omentum, and if needed, lengthening by division of vertical collaterals of gastroepiploic vessels section or thinning it out in patients with visceral obesity. This omental flap is ascended through the retromesentric route to cover all the peri-pancreatic vessels at risk of bleeding after pancreatic resection (hepatic artery, proximal part of the splenic artery, superior mesenteric artery, and right hepatic artery originating from superior mesenteric artery when present)
No omental flap or an omental flap not using the retromesenteric route and only interposed between the pancreatic anastomosis and the hepatic artery, or a single round ligament flap wrapping the hepatic artery only.