Randomized Controlled Trial Comparing Pancreaticoduodenectomies With or Without Complete Arterial Coverage by Omentoplasty in Patients With High Risk of Postoperative Pancreatic Fistula.

Status: Recruiting

Location: See location...

Intervention Type: Procedure

Study Type: Interventional

Study Phase: Not Applicable

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.

Eligibility

Participation Requirements

Sex: All

Minimum Age: 18

Healthy Volunteers: f

View:

• 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

Locations

Other Locations

France

Beaujon Hospital

RECRUITING

Clichy

Contact Information

Primary

Alain SAUVANET, MD, PhD

alain.sauvanet@aphp.fr

+33140875948

Backup

Safi DOKMAK, MD. PhD

safi.dokmak@aphp.fr

Time Frame

Start Date: 2024-10-22

Estimated Completion Date: 2027-01

Participants

Target number of participants: 150

Treatments

Experimental: Retromesenteric omental flap covering all exposed peripancreatic arteries

A J-shaped omental flap is created by extensive mobilization of the greater omentum, and if needed, lengthening by division of vertical collaterals of gastroepiploic vessels section or thinning it out in patients with visceral obesity. This omental flap is ascended through the retromesentric route to cover all the peri-pancreatic vessels at risk of bleeding after pancreatic resection (hepatic artery, proximal part of the splenic artery, superior mesenteric artery, and right hepatic artery originating from superior mesenteric artery when present)

Active_comparator: Control

No omental flap or an omental flap not using the retromesenteric route and only interposed between the pancreatic anastomosis and the hepatic artery, or a single round ligament flap wrapping the hepatic artery only.

Related Therapeutic Areas

Pancreatectomy

Gastric Bypass

Gastrointestinal Fistula

Pancreaticoduodenectomy

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Randomized Controlled Trial Comparing Pancreaticoduodenectomies With or Without Complete Arterial Coverage by Omentoplasty in Patients With High Risk of Postoperative Pancreatic Fistula.

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