NCT05992857 Pancreaticoduodenectomies With Complete Arterial Coverage by Retromesenteric Omentoplasty
| NCT ID | NCT05992857 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Assistance Publique - Hôpitaux de Paris |
| Condition | Pancreatectomy |
| Study Type | INTERVENTIONAL |
| Enrollment | 150 participants |
| Start Date | 2024-10-22 |
| Primary Completion | 2027-01 |
Trial Parameters
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Brief 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 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