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Belly flap may stop deadly bleeding after pancreatic surgery

NCT ID NCT05992857

Disease control Sponsor: Assistance Publique - Hôpitaux de Paris Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This trial tests a surgical technique to reduce severe bleeding after pancreatic head removal. In 150 high-risk patients, surgeons will either cover the exposed arteries with a flap of omental (belly) tissue or leave them uncovered. The goal is to see if the omental flap lowers the rate of dangerous bleeds that require transfusions or additional procedures.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
omentoplasty (using a flap of omental tissue to cover arteries)
What this could lead to
If it works, this could reduce life-threatening bleeding after pancreatic surgery, improving recovery and survival.
What could go wrong
This is a small, early-stage trial (150 people) testing a surgical technique. It may not show a clear benefit, and results may not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 150 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2024

Expected to finish

Jan 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Complication of surgical procedure Pancreatectomy

How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • Beaujon Hospital

    RECRUITING

    Clichy, 92118, France

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