Pancreaticoduodenectomies With Complete Arterial Coverage by Retromesenteric Omentoplasty (NCT05992857) | Clinical Trial Compass
RecruitingNot Applicable
Pancreaticoduodenectomies With Complete Arterial Coverage by Retromesenteric Omentoplasty
France150 participantsStarted 2024-10-22
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Rate of postpancreatectomy haemorrhage clinically significant (graded B or C)