Using a J-shaped retromesenteric omental flap to cover exposed arteries during pancreaticoduodenectomy
Randomized Controlled Trial Comparing Pancreaticoduodenectomies With or Without Complete Arterial Coverage by Omentoplasty in Patients With High Risk of Postoperative Pancreatic Fistula.
This study will test whether completely covering exposed peripancreatic arteries with a retromesenteric omental flap during pancreaticoduodenectomy reduces serious post‑operative bleeding in adults at high risk of pancreatic fistula.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 1 site (Clichy) |
| Trial ID | NCT05992857 on ClinicalTrials.gov |
What this trial studies
Adults scheduled for open pancreaticoduodenectomy who are found intraoperatively to have a high fistula risk score (FRS ≥ 7) are randomized during the operation to receive either a J‑shaped retromesenteric omental flap that covers all at‑risk arteries or the standard approach with partial or no arterial covering. The primary outcome is the incidence of clinically relevant grade B or C postpancreatectomy hemorrhage requiring transfusion or radiologic/surgical hemostasis. Patients are enrolled before surgery, randomized intraoperatively, and followed through discharge and at about postoperative day 45 with additional visits as needed. Reconstruction uses a pancreaticojejunostomy with an external pancreatic stent in all enrolled patients.
Who should consider this trial
Good fit: Ideal candidates are adults undergoing open pancreaticoduodenectomy with an intraoperative fistula risk score of at least 7, who will have reconstruction with pancreaticojejunostomy and an external stent and can consent to the protocol.
Not a fit: Patients with low fistula risk scores, those with prior abdominal surgery that prevents completion of the retromesenteric omentoplasty, patients requiring arterial resection, or those found to have distant metastases intraoperatively are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, the technique could reduce life‑threatening postpancreatectomy hemorrhage and the need for transfusions or additional invasive hemostatic procedures.
How similar studies have performed: No randomized controlled trials have tested complete retromesenteric arterial coverage; the approach is novel with only limited case series and surgical reports suggesting possible benefit.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Clichy
- Beaujon Hospital — Clichy, France (Recruiting)
Study contacts
- Principal investigator: Alain SAUVANET, MD, PhD — Assistance Publique - Hôpitaux de Paris
- Study coordinator: Alain SAUVANET, MD, PhD
- Email: alain.sauvanet@aphp.fr
- Phone: +33140875948
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.