Ignite Creation Date:
2025-12-24 @ 6:33 PM
Ignite Modification Date:
2025-12-28 @ 7:43 PM
Study NCT ID:
NCT05992857
Status:
RECRUITING
Last Update Posted:
2025-11-18
First Post:
2023-08-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pancreaticoduodenectomies With Complete Arterial Coverage by Retromesenteric Omentoplasty
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Study Overview
Official Title:
Randomized Controlled Trial Comparing Pancreaticoduodenectomies With or Without Complete Arterial Coverage by Omentoplasty in Patients With High Risk of Postoperative Pancreatic Fistula.
Status:
RECRUITING
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PACOMARCO
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: