Pancreaticoduodenectomies With Complete Arterial Coverage by Retromesenteric Omentoplasty

Launched by ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS · Aug 8, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at a new surgical technique to help reduce the risk of bleeding after a specific type of surgery called pancreaticoduodenectomy (PD). The researchers want to see if completely covering the arteries around the pancreas with a tissue flap (called retromesenteric omentoplasty) can help lower the chances of post-surgery bleeding that requires treatment, compared to partial coverage or no coverage at all. This trial is important for patients who are at a higher risk of complications after their surgery.

To be eligible for this study, participants need to be at least 18 years old and scheduled for a pancreaticoduodenectomy. They must have a certain score that indicates they are at risk for complications and should be able to understand and agree to follow the study rules. The trial is not open yet, but it will involve participants receiving the surgery and then being monitored for any bleeding issues afterward. Additionally, certain patients, such as those with previous abdominal surgeries or specific medical conditions, may not be able to take part. This study aims to improve the safety and outcomes for patients undergoing this type of surgery.

Gender

ALL

Eligibility 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.