Actively Recruiting
Pancreaticoduodenectomies With Complete Arterial Coverage by Retromesenteric Omentoplasty
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2025-11-18
150
Participants Needed
1
Research Sites
114 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Pancreaticoduodenectomies With Complete Arterial Coverage by Retromesenteric Omentoplasty
Who Can Participate
Eligibility Criteria
You may qualify if you...
-
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
You will not qualify if you...
- 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.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Beaujon Hospital
Clichy, France, 92118
Actively Recruiting
Research Team
A
Alain SAUVANET, MD, PhD
CONTACT
S
Safi DOKMAK, MD. PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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