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 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 150 participants in total. It began in 2024-10-22 with a primary completion date of 2027-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
Contact & Investigator
Alain SAUVANET, MD, PhD
PRINCIPAL INVESTIGATOR
Assistance Publique - Hôpitaux de Paris
Frequently Asked Questions
Who can join the NCT05992857 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Pancreatectomy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05992857 currently recruiting?
Yes, NCT05992857 is actively recruiting participants. Contact the research team at alain.sauvanet@aphp.fr for enrollment information.
Where is the NCT05992857 trial being conducted?
This trial is being conducted at Clichy, France.
Who is sponsoring the NCT05992857 clinical trial?
NCT05992857 is sponsored by Assistance Publique - Hôpitaux de Paris. The principal investigator is Alain SAUVANET, MD, PhD at Assistance Publique - Hôpitaux de Paris. The trial plans to enroll 150 participants.