xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05992857</url>
    </required_header>
    <id_info>
      <org_study_id>APHP220823</org_study_id>
      <nct_id>NCT05992857</nct_id>
    </id_info>
    <brief_title>PAncreaticoduodenectomies With COMplete ARterial Coverage by Retromesenteric Omentoplasty</brief_title>
    <acronym>PACOMARCO</acronym>
    <official_title>Randomized Controlled Trial Comparing PAncreaticoduodenectomies With or Without COMplete ARterial Coverage by Omentoplasty in Patients With High Risk of Postoperative Pancreatic Fistula.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Assistance Publique - Hôpitaux de Paris</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Assistance Publique - Hôpitaux de Paris</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        To assess the efficacy of complete covering using retromesenteric omentoplasty vs. partial&#xD;
        covering or no covering of peripancreatic arteries in decreasing incidence of grade B+C&#xD;
        post-pancreatectomy hemorrhage (PPH), i.e. treated by transfusion and / or radiological or&#xD;
        surgical hemostasis after PD in patients with high risk of POPF.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Grade B+C postpancreatectomy hemorrhage (PPH) is a severe complication following&#xD;
        pancreaticoduodenectomy (PD), more frequently observed in patients with high-risk of&#xD;
        postoperative pancreatic fistula (POPF). To date no randomized controlled trial has assessed&#xD;
        the impact of an omentoplasty covering all arteries exposed during PD on the prevention of&#xD;
        clinically relevant postpancreatectomy hemorrhage (PPH) in patients with high-risk of POPF&#xD;
        (fistula risk score between 7 to 10)&#xD;
  &#xD;
        In the standard technique, no omental flap is used or an omental flap is only interposed&#xD;
        between the pancreatic anastomosis and the hepatic artery, and/or the round ligament wraps&#xD;
        the hepatic artery only. An orignal approach is proposed using a J-shaped omental flap&#xD;
        created by the mobilization of the greater omentum and ascended through the retromesentric&#xD;
        route to cover all the peri-pancreatic arteries at risk of bleeding after pancreatic&#xD;
        resection.&#xD;
  &#xD;
        Patient fulfilling eligibility criteria will be enrolled during a selection visit (V0) which&#xD;
        may take place 45 days and up to 1 day prior PD surgery. Patient will be randomized&#xD;
        intra-operatively either in the experimental arm or the control arm for allocation the&#xD;
        omental covering technique.&#xD;
  &#xD;
        After surgery, the following visits will be planned for the patient follow up:&#xD;
  &#xD;
          -  V2: End of hospitalization visit which can be done up to 1 day prior discharge.&#xD;
  &#xD;
          -  V3: POD 45 (±15) days which will take place at the hospital.&#xD;
  &#xD;
          -  Vai: Additional visit which may take place if the patient is readmitted for&#xD;
             postoperative complication. Those visits may take place between V2 and V4 up to 1 day&#xD;
             prior discharge.&#xD;
  &#xD;
          -  V4: POD 90 (±15) days is the end of study visit. It will take place at the hospital.&#xD;
  &#xD;
        During those visits, data will be collected to validate the primary and secondary endpoints&#xD;
        of the trial.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 2023</start_date>
    <completion_date type="Anticipated">January 2027</completion_date>
    <primary_completion_date type="Anticipated">January 2027</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <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).&#xD;
  Randomization will be built by block of unequal size stratified by center and the prophylactic use of somatostatin/octreotide-Yes/No</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Rate of postpancreatectomy haemorrhage clinically significant (graded B or C)</measure>
      <time_frame>From surgery to post-operative day 90</time_frame>
      <description>According to the definition of the International Study Group of Pancreatic Surgery (ISGPS)&#xD;
  Grade B: PPH is early (&lt; 24h) or late bleeding without any organ failure&#xD;
  Grade C: PPH is late bleeding with organ failure (hemodynamic, renal, cardiac, respiratory failure)&#xD;
  Both grade B and C bleeding require transfusion and/or a procedure to obtain hemostasis including radiological embolization, endoscopic intervention or reoperation.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Mortality</measure>
      <time_frame>From surgery to post-operative day 90</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Overall Morbidity</measure>
      <time_frame>From surgery to post-operative day 90</time_frame>
      <description>Assessed by comprehensive complication index (CCI)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Rate of grade B+C post-operative pancreatic fistula</measure>
      <time_frame>From post-operative day 3 to post-operative day 90</time_frame>
      <description>According to 2016 ISGPF classification (Bassi C et al. 2016) :&#xD;
  -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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Rate of grade A post-pancreatectomy haemorrhage</measure>
      <time_frame>From surgery to post-operative day 90</time_frame>
      <description>[12:51] Alain (Invité)&#xD;
  Post pancreatectomy haemorrhage requiring neither transfusion nor hemostatic procedure</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Hospital readmission</measure>
      <time_frame>From end of initial hospital stay to post-operative day 90</time_frame>
      <description>Defined by unplanned readmission</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Total duration of hospital stay</measure>
      <time_frame>From surgery to post-operative day 90</time_frame>
      <description>Including duration of initial stay and readmision if present</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Rate of arterial pseudoaneurysm</measure>
      <time_frame>Performed at post-operative day 90</time_frame>
      <description>Detected by routine enhanced CT with intravenous contrast injection</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">150</enrollment>
    <condition>Pancreatectomy</condition>
    <condition>Complication of Surgical Procedure</condition>
    <arm_group>
      <arm_group_label>Retromesenteric omental flap covering all exposed peripancreatic arteries</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <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)</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <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.</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Pancreaticoduodenectomy</intervention_name>
      <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</description>
      <arm_group_label>Control</arm_group_label>
      <arm_group_label>Retromesenteric omental flap covering all exposed peripancreatic arteries</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age ≥ 18 years&#xD;
  &#xD;
            -  Patients requiring a pancreaticoduodenectomy (PD) for any indication&#xD;
  &#xD;
            -  Open approach&#xD;
  &#xD;
            -  Affiliation to the French public healthcare insurance&#xD;
  &#xD;
            -  Fistula risk score (FRS) ≥ 7 confirmed intraoperatively&#xD;
  &#xD;
            -  Ability to understand and to comply with the study protocol&#xD;
  &#xD;
            -  Reconstruction with PJ and external pancreatic stent&#xD;
  &#xD;
            -  Signed written informed consent&#xD;
  &#xD;
            -  Inclusion is allowed for patients:&#xD;
  &#xD;
                 -  On curative or long-term anticoagulation or aspirin (indicated for previous&#xD;
                    thromboembolic complications, heart disease, previous history of stroke)&#xD;
  &#xD;
                 -  Undergoing PD with venous resection&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Presence of distant tumor deposits (liver and peritoneal metastases, and/or&#xD;
               para-aortic lymph nodes metastases) reveals during intraoperative exploration for&#xD;
               patient with malignant pancreatic or periampullary tumor.&#xD;
  &#xD;
            -  Patients with previous abdominal surgery compromising completion of retromesenteric&#xD;
               omentoplasty&#xD;
  &#xD;
            -  PD with arterial resection (i.e. resection of hepatic artery, splenic artery, superior&#xD;
               mesenteric artery, or celiac axis)&#xD;
  &#xD;
            -  Laparoscopic or robotic PD&#xD;
  &#xD;
            -  Reconstruction wih pancreatico-gastrostomy&#xD;
  &#xD;
            -  Total pancreatectomy&#xD;
  &#xD;
            -  Emergency procedure&#xD;
  &#xD;
            -  Pregnant women&#xD;
  &#xD;
            -  Patient under guardianship and curatorship&#xD;
  &#xD;
            -  Participation in another interventional study evaluating complication after&#xD;
               pancreaticoduodenectomy or patient still being in the exclusion period at the end of a&#xD;
               previous study evaluating drugs.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Alain SAUVANET, MD</last_name>
      <phone>+33140875948</phone>
      <phone_ext>33</phone_ext>
      <email>alain.sauvanet@aphp.fr</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Safi DOKMAK, MD. Phd</last_name>
      <email>safi.dokmak@aphp.fr</email>
    </overall_contact_backup>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 8, 2023</study_first_submitted>
    <study_first_submitted_qc>August 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 15, 2023</study_first_posted>
    <last_update_submitted>August 8, 2023</last_update_submitted>
    <last_update_submitted_qc>August 8, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Pancreaticoduodenectomy</keyword>
    <keyword>Post-pancreatectomy haemorrhage</keyword>
    <keyword>Omentoplasty</keyword>
    <keyword>Post-operative pancreatic fistula</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Pancreatic Fistula</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05992857
  org study id: APHP220823
  nct id: NCT05992857
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  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.
  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.
  allocation: Randomized
  intervention model: Parallel Assignment
  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
  masking: None (Open Label)
  measure: Rate of postpancreatectomy haemorrhage clinically significant (graded B or C)
  time frame: From surgery to post-operative day 90
  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.
  measure: Mortality
  time frame: From surgery to post-operative day 90
  measure: Overall Morbidity
  time frame: From surgery to post-operative day 90
  description: Assessed by comprehensive complication index (CCI)
  measure: Rate of grade B+C post-operative pancreatic fistula
  time frame: From post-operative day 3 to post-operative day 90
  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.
  measure: Rate of grade A post-pancreatectomy haemorrhage
  time frame: From surgery to post-operative day 90
  description: [12:51] Alain (Invité)
  Post pancreatectomy haemorrhage requiring neither transfusion nor hemostatic procedure
  measure: Hospital readmission
  time frame: From end of initial hospital stay to post-operative day 90
  description: Defined by unplanned readmission
  measure: Total duration of hospital stay
  time frame: From surgery to post-operative day 90
  description: Including duration of initial stay and readmision if present
  measure: Rate of arterial pseudoaneurysm
  time frame: Performed at post-operative day 90
  description: Detected by routine enhanced CT with intravenous contrast injection
  arm group label: Retromesenteric omental flap covering all exposed peripancreatic arteries
  arm group type: Experimental
  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 group label: Control
  arm group type: Active Comparator
  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: Pancreaticoduodenectomy
  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
  arm group label: Control
  arm group label: Retromesenteric omental flap covering all exposed peripancreatic arteries
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Alain SAUVANET, MD
  phone: +33140875948
  phone ext: 33
  email: alain.sauvanet@aphp.fr
  last name: Safi DOKMAK, MD. Phd
  email: safi.dokmak@aphp.fr
  responsible party type: Sponsor
  mesh term: Pancreatic Fistula
  sharing ipd: Undecided