Pancreaticoduodenectomies With Complete Arterial Coverage by Retromesenteric Omentoplasty

Complication of Surgical Procedure Clinical Trial

— PACOMARCO  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05992857
• Other study ID #: APHP220823
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 2024
• Est. completion date: January 2027

Study information

• Verified date: August 2023
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Alain SAUVANET, MD
• Phone: +33140875948
• Email: alain.sauvanet[@]aphp.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: January 2027
• Est. primary completion date: January 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Complication of Surgical Procedure
• Pancreatectomy
• Pancreatic Fistula

Intervention

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.
• Pancreaticoduodenectomy with retromesenteric omental flap
All exposed peripancratic arteries should be covered with a retromesentric omental flap

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Mortality		From surgery to post-operative day 90
Secondary	Overall Morbidity	Assessed by comprehensive complication index (CCI)	From surgery to post-operative day 90
Secondary	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
Secondary	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
Secondary	Hospital readmission	Defined by unplanned readmission	From end of initial hospital stay to post-operative day 90
Secondary	Total duration of hospital stay	Including duration of initial stay and readmision if present	From surgery to post-operative day 90
Secondary	Rate of arterial pseudoaneurysm	Detected by routine enhanced CT with intravenous contrast injection	Performed at post-operative day 90