Clinical trial NCT05992857: Pancreaticoduodenectomies With Complete Arterial Coverage by Retromesenteric Omentoplasty
Official title: Randomized Controlled Trial Comparing Pancreaticoduodenectomies With or Without Complete Arterial Coverage by Omentoplasty in Patients With High Risk of Postoperative Pancreatic Fistula.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pancreatectomy
Complication of Surgical Procedure
Keywords: Pancreaticoduodenectomy
Post-pancreatectomy haemorrhage
Omentoplasty
Post-operative pancreatic fistula
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2023-08-15
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Rate of postpancreatectomy haemorrhage clinically significant (graded B or C)
timeFrame: From surgery to post-operative day 90
Secondary outcomes:
measure: Mortality
timeFrame: From surgery to post-operative day 90
measure: Overall Morbidity
timeFrame: From surgery to post-operative day 90
measure: Rate of grade B+C post-operative pancreatic fistula
timeFrame: From post-operative day 3 to post-operative day 90
measure: Rate of grade A post-pancreatectomy haemorrhage
timeFrame: From surgery to post-operative day 90
measure: Hospital readmission
timeFrame: From end of initial hospital stay to post-operative day 90
measure: Total duration of hospital stay
timeFrame: From surgery to post-operative day 90
measure: Rate of arterial pseudoaneurysm
timeFrame: Performed at post-operative day 90
Other outcomes:
Locations:
Study officials:
References: