search
Back to results

PAncreaticoduodenectomies With COMplete ARterial Coverage by Retromesenteric Omentoplasty (PACOMARCO)

Primary Purpose

Pancreatectomy, Complication of Surgical Procedure

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Pancreaticoduodenectomy
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatectomy focused on measuring Pancreaticoduodenectomy, Post-pancreatectomy haemorrhage, Omentoplasty, Post-operative pancreatic fistula

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Retromesenteric omental flap covering all exposed peripancreatic arteries

    Control

    Arm Description

    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 obesity. This omental flap is ascended through the retromesentric route to cover all the peri-pancreatic vessels at risk of bleeding after pancreatic resection (hepatic artery, proximal part of the splenic artery, superior mesenteric artery, and right hepatic artery originating from superior mesenteric artery when present)

    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.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Mortality
    Overall Morbidity
    Assessed by comprehensive complication index (CCI)
    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.
    Rate of grade A post-pancreatectomy haemorrhage
    [12:51] Alain (Invité) Post pancreatectomy haemorrhage requiring neither transfusion nor hemostatic procedure
    Hospital readmission
    Defined by unplanned readmission
    Total duration of hospital stay
    Including duration of initial stay and readmision if present
    Rate of arterial pseudoaneurysm
    Detected by routine enhanced CT with intravenous contrast injection

    Full Information

    First Posted
    August 8, 2023
    Last Updated
    August 8, 2023
    Sponsor
    Assistance Publique - Hôpitaux de Paris
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT05992857
    Brief Title
    PAncreaticoduodenectomies With COMplete ARterial Coverage by Retromesenteric Omentoplasty
    Acronym
    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.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 2023 (Anticipated)
    Primary Completion Date
    January 2027 (Anticipated)
    Study Completion Date
    January 2027 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Assistance Publique - Hôpitaux de Paris

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pancreatectomy, Complication of Surgical Procedure
    Keywords
    Pancreaticoduodenectomy, Post-pancreatectomy haemorrhage, Omentoplasty, Post-operative pancreatic fistula

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    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
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    150 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Retromesenteric omental flap covering all exposed peripancreatic arteries
    Arm Type
    Experimental
    Arm Description
    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 obesity. This omental flap is ascended through the retromesentric route to cover all the peri-pancreatic vessels at risk of bleeding after pancreatic resection (hepatic artery, proximal part of the splenic artery, superior mesenteric artery, and right hepatic artery originating from superior mesenteric artery when present)
    Arm Title
    Control
    Arm Type
    Active Comparator
    Arm Description
    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.
    Intervention Type
    Procedure
    Intervention Name(s)
    Pancreaticoduodenectomy
    Intervention Description
    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
    Primary Outcome Measure Information:
    Title
    Rate of postpancreatectomy haemorrhage clinically significant (graded B or C)
    Description
    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 90
    Secondary Outcome Measure Information:
    Title
    Mortality
    Time Frame
    From surgery to post-operative day 90
    Title
    Overall Morbidity
    Description
    Assessed by comprehensive complication index (CCI)
    Time Frame
    From surgery to post-operative day 90
    Title
    Rate of grade B+C post-operative pancreatic fistula
    Description
    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 90
    Title
    Rate of grade A post-pancreatectomy haemorrhage
    Description
    [12:51] Alain (Invité) Post pancreatectomy haemorrhage requiring neither transfusion nor hemostatic procedure
    Time Frame
    From surgery to post-operative day 90
    Title
    Hospital readmission
    Description
    Defined by unplanned readmission
    Time Frame
    From end of initial hospital stay to post-operative day 90
    Title
    Total duration of hospital stay
    Description
    Including duration of initial stay and readmision if present
    Time Frame
    From surgery to post-operative day 90
    Title
    Rate of arterial pseudoaneurysm
    Description
    Detected by routine enhanced CT with intravenous contrast injection
    Time Frame
    Performed at post-operative day 90

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Alain SAUVANET, MD
    Phone
    +33140875948
    Ext
    33
    Email
    alain.sauvanet@aphp.fr
    First Name & Middle Initial & Last Name or Official Title & Degree
    Safi DOKMAK, MD. Phd
    Email
    safi.dokmak@aphp.fr

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

    PAncreaticoduodenectomies With COMplete ARterial Coverage by Retromesenteric Omentoplasty

    We'll reach out to this number within 24 hrs