Pancreaticoduodenectomies With Complete Arterial Coverage by Retromesenteric Omentoplasty
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAssistance Publique - Hôpitaux de Paris
About this trial
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
Qualifiers
Age ≥ 18 years
Patients requiring a pancreaticoduodenectomy (PD) for any indication
Open approach
Affiliation to the French public healthcare insurance
Disqualifiers
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
Trial design
Treatments tested in this trial
- Pancreaticoduodenectomy without retromesenteric omental flap
- Pancreaticoduodenectomy with retromesenteric omental flap
Treatment groups
150 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov