Pancreaticoduodenectomies With Complete Arterial Coverage by Retromesenteric Omentoplasty

NCT05992857 | Recruiting

• 1 other identifier: APHP220823
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatectomy; Complication of Surgical Procedure

Keywords

Pancreaticoduodenectomy; Post-pancreatectomy haemorrhage; Omentoplasty; Post-operative pancreatic fistula

Outcome Measures

Primary Outcomes (1)

• Rate of postpancreatectomy haemorrhage clinically significant (graded B or C)

  According to the definition of the International Study Group of Pancreatic Surgery (ISGPS) * Grade B: PPH is early (\< 24h) or late bleeding without any organ failure * Grade C: PPH is late bleeding with organ failure (hemodynamic, renal, cardiac, respiratory failure) * Both grade B and C bleeding require transfusion and/or a procedure to obtain hemostasis including radiological embolization, endoscopic intervention or reoperation.

  From surgery to post-operative day 90

Secondary Outcomes (7)

• Mortality

  From surgery to post-operative day 90

• Overall Morbidity

  From surgery to post-operative day 90

• Rate of grade B+C post-operative pancreatic fistula

  From post-operative day 3 to post-operative day 90

• Rate of grade A post-pancreatectomy haemorrhage

  From surgery to post-operative day 90

• Hospital readmission

  From end of initial hospital stay to post-operative day 90

Study Arms (2)

Retromesenteric omental flap covering all exposed peripancreatic arteries

EXPERIMENTAL

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)

Procedure: Pancreaticoduodenectomy with retromesenteric omental flap

Control

ACTIVE COMPARATOR

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.

Procedure: Pancreaticoduodenectomy without retromesenteric omental flap

Interventions

Pancreaticoduodenectomy without retromesenteric omental flap 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.

Control

Pancreaticoduodenectomy with retromesenteric omental flap PROCEDURE

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

Retromesenteric omental flap covering all exposed peripancreatic arteries

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• On curative or long-term anticoagulation or aspirin (indicated for previous thromboembolic complications, heart disease, previous history of stroke)
• Undergoing PD with venous resection

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Beaujon Hospital

Clichy, 92118, France

RECRUITING

MeSH Terms

Interventions

Pancreaticoduodenectomy

Intervention Hierarchy (Ancestors)

Digestive System Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Alain SAUVANET, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alain SAUVANET, MD, PhD

CONTACT

+33140875948; alain.sauvanet@aphp.fr

Safi DOKMAK, MD. PhD

CONTACT

safi.dokmak@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: National, Phase IIIb multicenter, centrally randomized open-label trial with two parallel arms. Participants will be distributed between the two arms at a ratio (1:1). Randomization will be built by block of unequal size stratified by center and the prophylactic use of somatostatin/octreotide-Yes/No

Study Record Dates

• First Submitted: August 8, 2023
• First Posted: August 15, 2023
• Study Start: October 22, 2024
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: November 18, 2025

Record last verified: 2025-11

Locations

FR (1)