Pancreaticoduodenectomies With Complete Arterial Coverage by Retromesenteric Omentoplasty

NCT ID: NCT05992857

Last Updated: 2025-11-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-22
• Study Completion Date: 2027-01-31

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 hemorrhage (PPH), i.e. treated by transfusion and / or radiological or surgical hemostasis after PD in patients with high risk of POPF.

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 (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.

Conditions

Pancreatectomy; Complication of Surgical Procedure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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)

Group Type: EXPERIMENTAL

Pancreaticoduodenectomy with retromesenteric omental flap

Intervention Type: PROCEDURE

All exposed peripancratic arteries should be covered with a retromesentric omental flap

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.

Group Type: ACTIVE_COMPARATOR

Pancreaticoduodenectomy without retromesenteric omental flap

Intervention Type: PROCEDURE

Resection of the pancreatic head, duodenum, distal common bile duct and gallbladder followed by reconstruction using pancreaticojejunostomy, hepaticojejunostomy, and gastrojejunostomy performed on the first jejunal loop.

Interventions

Pancreaticoduodenectomy without retromesenteric omental flap

Resection of the pancreatic head, duodenum, distal common bile duct and gallbladder followed by reconstruction using pancreaticojejunostomy, hepaticojejunostomy, and gastrojejunostomy performed on the first jejunal loop.

Intervention Type: PROCEDURE

Pancreaticoduodenectomy with retromesenteric omental flap

All exposed peripancratic arteries should be covered with a retromesentric omental flap

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alain SAUVANET, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

Beaujon Hospital

Clichy, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Alain SAUVANET, MD, PhD

Role: CONTACT

alain.sauvanet@aphp.fr

+33140875948 ext. 33

Safi DOKMAK, MD. PhD

Role: CONTACT

safi.dokmak@aphp.fr

Facility Contacts

Alain SAUVANET, MD, PHD

Role: primary

alain.sauvanet@aphp.fr

Other Identifiers

APHP220823

Identifier Type: -

Identifier Source: org_study_id