Pancreaticoduodenectomies With Complete Arterial Coverage by Retromesenteric Omentoplasty
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAssistance Publique - Hôpitaux de Paris
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years
Patients requiring a pancreaticoduodenectomy (PD) for any indication
Open approach
Affiliation to the French public healthcare insurance
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Pancreaticoduodenectomy without retromesenteric omental flap
Procedure/SurgeryResection 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
Procedure/SurgeryAll exposed peripancratic arteries should be covered with a retromesentric omental flap
Treatment groups
150 Participants
are divided into 2 treatment groupsGroup A: Retromesenteric omental flap covering all exposed peripancreatic arteriesExperimental treatment 1 intervention
Group B: ControlActive comparator 1 intervention
Trial outcomes
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.
Time frame
From surgery to post-operative day 90Secondary outcomes
1
Mortality
Time frame
From surgery to post-operative day 902
Overall Morbidity
Assessed by comprehensive complication index (CCI)
Time frame
From surgery to post-operative day 903
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.
Time frame
From post-operative day 3 to post-operative day 904
Rate of grade A post-pancreatectomy haemorrhage
\[12:51\] Alain (Invité) Post pancreatectomy haemorrhage requiring neither transfusion nor hemostatic procedure
Time frame
From surgery to post-operative day 90Sponsors and contacts
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Source ClinicalTrials.gov