Status:
RECRUITING
Pancreaticoduodenectomies With Complete Arterial Coverage by Retromesenteric Omentoplasty
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Pancreatectomy
Complication of Surgical Procedure
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 h...
Detailed Description
Grade B+C postpancreatectomy hemorrhage (PPH) is a severe complication following pancreaticoduodenectomy (PD), more frequently observed in patients with high-risk of postoperative pancreatic fistula (...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 22 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2027
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT05992857
Start Date
October 22 2024
End Date
January 1 2027
Last Update
November 18 2025
Active Locations (1)
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1
Beaujon Hospital
Clichy, France, 92118