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.
Assistance Publique - Hôpitaux de Paris
150 participants
Oct 22, 2024
INTERVENTIONAL
Conditions
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
Inclusion Criteria11
- 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 Criteria10
- 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.
Interventions
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.
All exposed peripancratic arteries should be covered with a retromesentric omental flap
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05992857