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Clinical trial Recruiting at 1 site Interventional Ages 18 and up

Using a J-shaped retromesenteric omental flap to cover exposed arteries during pancreaticoduodenectomy

Official title: Randomized Controlled Trial Comparing Pancreaticoduodenectomies With or Without Complete Arterial Coverage by Omentoplasty in Patients With High Risk of Postoperative Pancreatic Fistula.

Run by Assistance Publique - Hôpitaux de Paris · NCT05992857 · Data updated 2026-11-12

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.

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Quick facts

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment150 (estimated)
SponsorAssistance Publique - Hôpitaux de Paris
Academic / other
Locations1 site (Clichy)
StatusRecruiting
StartedOctober 22, 2024
Main results expectedJanuary 2027
Study endsJanuary 2027
Registry record updatedNovember 18, 2025
Trial IDNCT05992857 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

Who can join: the full rules

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 it's running

  • 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.