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Randomized Controlled Trial Comparing PAncreaticoduodenectomies With or Without COMplete ARterial Coverage by Omentoplasty in Patients With High Risk of Postoperative Pancreatic Fistula: Surgery – Pancreaticoduodenectomy
Disease Prevention Daily
2023 AUG 28 (NewsRx) -- By a
As a matter of record, on
Tracking Information
| Trial Identifier | NCT05992857 |
| First Submitted Date | |
| First Posted Date | |
| Results First Submitted Date | Not Provided |
| Results First Posted Date | Not Provided |
| Last Update Submitted Date | |
| Last Update Posted Date | |
| Primary Completion Date | |
| Start Date | |
| Current Primary Outcome Measures | •Rate of postpancreatectomy haemorrhage clinically significant (graded B or C) [ Time Frame: From surgery to post-operative day 90 ] -- According to the definition of the |
| Current Secondary Outcome Measures | •Mortality [ Time Frame: From surgery to post-operative day 90 ] |
| •Overall Morbidity [ Time Frame: From surgery to post-operative day 90 ] -- Assessed by comprehensive complication index (CCI) | |
| •Rate of grade B+C post-operative pancreatic fistula [ Time Frame: From post-operative day 3 to post-operative day 90 ] -- 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. | |
| •Rate of grade A post-pancreatectomy haemorrhage [ Time Frame: From surgery to post-operative day 90 ] -- [12:51] |
|
| •Hospital readmission [ Time Frame: From end of initial hospital stay to post-operative day 90 ] -- Defined by unplanned readmission | |
| •Total duration of hospital stay [ Time Frame: From surgery to post-operative day 90 ] -- Including duration of initial stay and readmision if present | |
| •Rate of arterial pseudoaneurysm [ Time Frame: Performed at post-operative day 90 ] -- Detected by routine enhanced CT with intravenous contrast injection | |
| Other Outcome Measures | Not Provided |
| Change History | Complete list of historical revisions of study NCT05992857 |
Descriptive Information
| Brief Title | 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. |
| 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. |
| Study Type | Interventional |
| Study Phase | Not Applicable |
| Study Design | Allocation: Randomized |
| Intervention Model: Parallel Assignment | |
| Primary Purpose: Treatment | |
| Masking: None (Open Label) | |
| 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 | |
| Condition | Pancreatectomy |
| Complication of Surgical Procedure | |
| Intervention | •Procedure: Pancreaticoduodenectomy |
| 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 | |
| Study Arms | •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. | |
| Interventions: | |
| ⚬Procedure: Pancreaticoduodenectomy | |
| •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 o | |
| Interventions: | |
| ⚬Procedure: Pancreaticoduodenectomy |
Recruitment Information
| Recruitment Status | Not yet recruiting |
| Estimated Enrollment | 150 |
| Estimated Completion Date | |
| Primary Completion Date | |
| 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. |
| Sex/Gender | Sexes Eligible for Study: All |
| Ages | 18 years and older |
| No | |
| Contacts | Primary contact: Alain SAUVANET, MD, +33140875948, [email protected] |
| Backup contact: Safi DOKMAK, MD. Phd, , [email protected] | |
| Listed Location Countries | Not Provided |
| Removed Location Countries |
Administrative Information
| NCT Number | NCT05992857 |
| Other Study ID Numbers | APHP220823 |
| Has Data Monitoring Committee | Not Provided |
| Not Provided | |
| Plan to Share Data (IPD) Description | Not Provided |
| Assistance Publique - Hopitaux de |
|
| Collaborators | Not Provided |
| Investigators | Not Provided |
| Information Provided By | Assistance Publique - Hopitaux de |
| Verification Date |
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