<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/NCT03030170</url>
  </required_header>
  <id_info>
    <org_study_id>35RC15_9846</org_study_id>
    <nct_id>NCT03030170</nct_id>
  </id_info>
  <brief_title>REinforcement of the Pancreas in distaL pAncreatectomY (REPLAY)</brief_title>
  <acronym>REPLAY</acronym>
  <official_title>Does the Strengthening of the Pancreas in Distal Pancreatectomy Using Endo GIA Reload Reinforced Reduce the Occurrence of Pancreatic Fistula? Multicenter Randomized Prospective Open Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rennes University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Rennes University Hospital</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Despite an improvement regarding morbidity and mortality since 30 years, especially in expert&#xD;
      centers, pancreatic surgery remains currently associated to a significant postoperative&#xD;
      morbidity reaching more than 60%. Regarding distal pancreatectomy (DP), the main complication&#xD;
      following surgery is the occurrence of postoperative pancreatic fistula (PF) which may be&#xD;
      able to lead an increased risk of bleeding, gastroparesis and finally a longer hospital&#xD;
      stays. The main risk factors associated to the occurrence of pancreatic fistula are&#xD;
      represented by the texture of the pancreatic parenchyma (soft pancreas) and the caliber of&#xD;
      the main pancreatic duct (&lt;3mm). Looking for new means of reducing the occurrence of&#xD;
      pancreatic fistula is a priority in pancreatic surgery and a genuine public health issue.&#xD;
      Currently, no formal recommendations concerning the optimal technical for closure of the&#xD;
      distal stump in DP are available. In fact, manual closing by elective suturing or stapling of&#xD;
      the main pancreatic duct give similar results. The use of a reinforcing stapling potentially&#xD;
      represents a simple way to decrease the occurrence of pancreatic fistula and requires&#xD;
      evaluation by a prospective randomized study.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 28, 2017</start_date>
  <completion_date type="Actual">July 30, 2021</completion_date>
  <primary_completion_date type="Actual">December 14, 2020</primary_completion_date>
  <phase>Phase 3</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>intervention with reinforced medical device, or not</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Rate of postoperative pancreatic fistula defined by the criteria of the ISGPF</measure>
    <time_frame>up to 90 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Gravity of the pancreatic fistula according to the 3 stages of ISGPF</measure>
    <time_frame>up to 90 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of the occurrence of gastroparesis and its severity according to the criteria of ISGPS</measure>
    <time_frame>up to 90 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of the occurrence of postoperative haemorrhage</measure>
    <time_frame>up to 90 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of hospital stay</measure>
    <time_frame>up to 90 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Perioperative mortality and 90-day mortality</measure>
    <time_frame>up to 90 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall morbidity classified and categorized according to the classification of Dindo and Clavien</measure>
    <time_frame>until 90 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rehospitalization rates</measure>
    <time_frame>until 90 days</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">207</enrollment>
  <condition>Distal Pancreatectomy (DP)</condition>
  <arm_group>
    <arm_group_label>Experimental</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Stapling of the pancreas with ENDO GIA Reinforced reload</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Stapling of the pancreas with ENDO GIA X-tra Thick reload</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>ENDO GIA X-tra Thick reload with Tri Staple Technology</intervention_name>
    <description>Suture of the pancreas by normal stapling</description>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>ENDO GIA Articulating Reinforced Reload with Tri-Staple Technology</intervention_name>
    <description>Suture of the pancreas by reinforced stapling</description>
    <arm_group_label>Experimental</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All patients who undergo DP whether made by open or laparoscopic surgery&#xD;
&#xD;
          -  Patients 18 years of age or older,&#xD;
&#xD;
          -  Benefiting from a social security scheme,&#xD;
&#xD;
          -  Having given his free, informed and written consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of pancreatic abdominal surgery&#xD;
&#xD;
          -  Severe co-morbidity type renal failure requiring hemodialysis, unbalanced diabetes,&#xD;
             major respiratory insufficiency, heart failure ≥ stage 3 NYHA;&#xD;
&#xD;
          -  Persons of full age who are subject to legal protection, persons deprived of liberty.&#xD;
&#xD;
          -  Pregnant or nursing women&#xD;
&#xD;
          -  Patients participating in or participating in another study&#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_official>
    <last_name>LAURENT SULPICE, MD/PHD</last_name>
    <role>Principal Investigator</role>
    <affiliation>RENNES PONTCHAILLOU HOSPITAL</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Service de chirurgie Hépato-pancréato-biliaire</name>
      <address>
        <city>Clichy</city>
        <zip>92110</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Service de chirurgie générale, digestive et de la transplantation hépatique</name>
      <address>
        <city>Lyon</city>
        <zip>69317</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AP-HM - Institut Paoli Calmettes_ service de chirurgie oncologique digestive</name>
      <address>
        <city>Marseille</city>
        <zip>13009</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Service de chirurgie digestive et endocrienne</name>
      <address>
        <city>Nantes</city>
        <zip>44093</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut Mutualiste Montsouris</name>
      <address>
        <city>Paris 14</city>
        <zip>75674</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Universitaire Rennes Pontchaillou</name>
      <address>
        <city>Rennes</city>
        <zip>35000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Unité d'hospitalisation Chirurgie hépatique, biliaire et pancréatique</name>
      <address>
        <city>Villejuif</city>
        <zip>94800</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>January 16, 2017</study_first_submitted>
  <study_first_submitted_qc>January 23, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 24, 2017</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 9, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT03030170
org study id: 35RC15_9846
nct id: NCT03030170
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Despite an improvement regarding morbidity and mortality since 30 years, especially in expert
      centers, pancreatic surgery remains currently associated to a significant postoperative
      morbidity reaching more than 60%. Regarding distal pancreatectomy (DP), the main complication
      following surgery is the occurrence of postoperative pancreatic fistula (PF) which may be
      able to lead an increased risk of bleeding, gastroparesis and finally a longer hospital
      stays. The main risk factors associated to the occurrence of pancreatic fistula are
      represented by the texture of the pancreatic parenchyma (soft pancreas) and the caliber of
      the main pancreatic duct (<3mm). Looking for new means of reducing the occurrence of
      pancreatic fistula is a priority in pancreatic surgery and a genuine public health issue.
      Currently, no formal recommendations concerning the optimal technical for closure of the
      distal stump in DP are available. In fact, manual closing by elective suturing or stapling of
      the main pancreatic duct give similar results. The use of a reinforcing stapling potentially
      represents a simple way to decrease the occurrence of pancreatic fistula and requires
      evaluation by a prospective randomized study.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: intervention with reinforced medical device, or not
primary purpose: Other
masking: None (Open Label)
measure: Rate of postoperative pancreatic fistula defined by the criteria of the ISGPF
time frame: up to 90 days
measure: Gravity of the pancreatic fistula according to the 3 stages of ISGPF
time frame: up to 90 days
measure: Assessment of the occurrence of gastroparesis and its severity according to the criteria of ISGPS
time frame: up to 90 days
measure: Evaluation of the occurrence of postoperative haemorrhage
time frame: up to 90 days
measure: Length of hospital stay
time frame: up to 90 days
measure: Perioperative mortality and 90-day mortality
time frame: up to 90 days
measure: Overall morbidity classified and categorized according to the classification of Dindo and Clavien
time frame: until 90 days
measure: Rehospitalization rates
time frame: until 90 days
arm group label: Experimental
arm group type: Experimental
description: Stapling of the pancreas with ENDO GIA Reinforced reload
arm group label: Control
arm group type: Active Comparator
description: Stapling of the pancreas with ENDO GIA X-tra Thick reload
intervention type: Device
intervention name: ENDO GIA X-tra Thick reload with Tri Staple Technology
description: Suture of the pancreas by normal stapling
arm group label: Control
intervention type: Device
intervention name: ENDO GIA Articulating Reinforced Reload with Tri-Staple Technology
description: Suture of the pancreas by reinforced stapling
arm group label: Experimental
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: LAURENT SULPICE, MD/PHD
role: Principal Investigator
affiliation: RENNES PONTCHAILLOU HOSPITAL
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: France
responsible party type: Sponsor
sharing ipd: Undecided