Pancreaticoduodenectomies With Complete Arterial Coverage by

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial 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 (POPF). To date no randomized controlled trial has assessed the impact of an omentoplasty covering all arteries exposed during PD on the prevention of clinically relevant postpancreatectomy hemorrhage (PPH) in patients with high-risk of POPF (fistula risk score between 7 to 10) In the standard technique, no omental flap is used or an omental flap is only interposed between the pancreatic anastomosis and the hepatic artery, and/or the round ligament wraps the hepatic artery only. An orignal approach is proposed using a J-shaped omental flap created by the mobilization of the greater omentum and ascended through the retromesentric route to cover all the peri-pancreatic arteries at risk of bleeding after pancreatic resection. Patient fulfilling eligibility criteria will be enrolled during a selection visit (V0) which may take place 45 days and up to 1 day prior PD surgery. Patient will be randomized intra-operatively either in the experimental arm or the control arm for allocation the omental covering technique. After surgery, the following visits will be planned for the patient follow up: - V2: End of hospitalization visit which can be done up to 1 day prior discharge. - V3: POD 45 (±15) days which will take place at the hospital. - Vai: Additional visit which may take place if the patient is readmitted for postoperative complication. Those visits may take place between V2 and V4 up to 1 day prior discharge. - V4: POD 90 (±15) days is the end of study visit. It will take place at the hospital. During those visits, data will be collected to validate the primary and secondary endpoints of the trial. ;

Study Design

Related Conditions & MeSH terms

Complication of Surgical Procedure
Pancreatectomy
Pancreatic Fistula

Clinical Trial Details

NCT number	NCT05992857
Study type	Interventional
Source	Assistance Publique - Hôpitaux de Paris
Contact	Alain SAUVANET, MD
Phone	+33140875948
Email	alain.sauvanet@aphp.fr
Status	Not yet recruiting
Phase	N/A
Start date	February 2024
Completion date	January 2027

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Pancreaticoduodenectomies With Complete Arterial Coverage by Retromesenteric Omentoplasty — PACOMARCO

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms