Pancreaticoduodenectomies With Complete Arterial Coverage by Retromesenteric Omentoplasty (PACOMARCO)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Complication of Surgical Procedure; Pancreatectomy
• Intervention / Treatment: Procedure: Pancreaticoduodenectomy with retromesenteric omental flap; Procedure: Pancreaticoduodenectomy without retromesenteric omental flap

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.

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Safi DOKMAK, MD. PhD; Email: safi.dokmak@aphp.fr
• Study Contact Backup: Name: Alain SAUVANET, MD, PhD; Phone Number: 33 +33140875948; Email: alain.sauvanet@aphp.fr

Study Locations

• France
  • Clichy, France, 92118
    • Recruiting
    • Beaujon Hospital
    • Contact: Alain SAUVANET, MD, PHD; Email: alain.sauvanet@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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)	Procedure: Pancreaticoduodenectomy with retromesenteric omental flap; All exposed peripancratic arteries should be covered with a retromesentric omental flap
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.	Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality		From surgery to post-operative day 90
Overall Morbidity	Assessed by comprehensive complication index (CCI)	From surgery to post-operative day 90
Rate of grade B+C post-operative pancreatic fistula	According to 2016 ISGPF classification (Bassi C et al. 2016) : -Amylase level in the drainage fluid (or fluid of any collection) exceeding 3 times the upper limit of local laboratory norm of serum amylase level co-existing with clinically significant deviation from the normal post operative course.	From post-operative day 3 to post-operative day 90
Rate of grade A post-pancreatectomy haemorrhage	[12:51] Alain (Invité) Post pancreatectomy haemorrhage requiring neither transfusion nor hemostatic procedure	From surgery to post-operative day 90
Hospital readmission	Defined by unplanned readmission	From end of initial hospital stay to post-operative day 90
Total duration of hospital stay	Including duration of initial stay and readmision if present	From surgery to post-operative day 90
Rate of arterial pseudoaneurysm	Detected by routine enhanced CT with intravenous contrast injection	Performed at post-operative day 90

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Alain SAUVANET, MD, PhD, Assistance Publique - Hopitaux de Paris

Study record dates

Study Major Dates

• Study Start (Actual): October 22, 2024
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: August 8, 2023
• First Submitted That Met QC Criteria: August 8, 2023
• First Posted (Actual): August 15, 2023

Study Record Updates

• Last Update Posted (Actual): November 18, 2025
• Last Update Submitted That Met QC Criteria: November 17, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Pancreaticoduodenectomy; Post-operative pancreatic fistula; Post-pancreatectomy haemorrhage; Omentoplasty
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Digestive System Diseases; Pancreatic Diseases; Digestive System Fistula; Fistula; Pancreatic Fistula; Surgical Procedures, Operative; Digestive System Surgical Procedures; Pancreaticoduodenectomy
• Other Study ID Numbers: APHP220823

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No