<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/NCT03030573</url>
  </required_header>
  <id_info>
    <org_study_id>Beaujon Hospital</org_study_id>
    <nct_id>NCT03030573</nct_id>
  </id_info>
  <brief_title>Reconstruction of the Bile Duct With the Round Ligament</brief_title>
  <official_title>Reconstruction of Postcholecystectomy Bile Duct Injury and Bile Duct Defects With the Round Ligament</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Beaujon Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Beaujon Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators developed a new surgical technique in order to reconstruct the bile duct&#xD;
      with the round ligament&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Classically, the bile duct defect after bile duct injury or resection is achieved by&#xD;
      bilioenteric reconstruction. However bilioenteric anastomosis is associated with long term&#xD;
      complications including intrahepatic bile ducts infection, specific complications related to&#xD;
      the Roux en Y jejunal loop and eliminate the endoscopic access to intrahepatic bile ducts.&#xD;
      The investigators had recently developed a new surgical technique to reconstruct the veins&#xD;
      with the parietal peritoneum with excellent results. Accordingly the investigators decided to&#xD;
      develop a new surgical technique in order to reconstruct the bile duct defects with the&#xD;
      vascularized round ligament.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>November 2015</start_date>
  <completion_date type="Anticipated">November 2018</completion_date>
  <primary_completion_date type="Anticipated">November 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Safety - absence of any severe complication or mortality related to the new procedure</measure>
    <time_frame>at 1 year</time_frame>
    <description>Safety is defined by the absence of any severe complication (necrosis or biliary fistula) or mortality related to the new procedure.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Bile buct patency</measure>
    <time_frame>at 3 year</time_frame>
    <description>Secondary outcome include mainly the patency of the reconstructed bile duct.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Bile Duct Obstruction, Extrahepatic</condition>
  <arm_group>
    <arm_group_label>Device: Round ligament and the bile duct</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>The investigators describe the safety and efficacy of the reconstruction of the bile duct with the Round ligament.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Reconstruction of the bile duct with the round ligament</intervention_name>
    <description>In patients who had bile duct defect by injury or resection, the Round ligament will be used to reconstruct the defect. Surgical technique, the early and long term postoperative measures are detailed in the investigators protocol.</description>
    <arm_group_label>Device: Round ligament and the bile duct</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Radiological or operative diagnosis of bile duct Injury or defect&#xD;
&#xD;
          2. Can underwent surgical procedure&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        1) The absence of the round ligament&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Safi Dokmak, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>HBP department, Beaujon hospital, Clichy, France</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Safi Dokmak, MD</last_name>
    <phone>0033140875797</phone>
    <email>safi.dokmak@aphp.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Departement HPB surgery, Beaujon Hospital</name>
      <address>
        <city>Clichy</city>
        <state>Hauts de seine</state>
        <zip>92110</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Safi Dokmak, MD</last_name>
      <phone>0033140875797</phone>
      <email>safi.dokmak@bjn.aphp.fr</email>
    </contact>
    <investigator>
      <last_name>Safi Dokmak, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>February 2017</verification_date>
  <study_first_submitted>November 19, 2016</study_first_submitted>
  <study_first_submitted_qc>January 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 25, 2017</study_first_posted>
  <last_update_submitted>February 5, 2017</last_update_submitted>
  <last_update_submitted_qc>February 5, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 7, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Beaujon Hospital</investigator_affiliation>
    <investigator_full_name>Safi Dokmak</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <keyword>Bile duct injury</keyword>
  <keyword>Bile duct defect</keyword>
  <keyword>Round ligament</keyword>
  <keyword>Reconstruction</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cholestasis</mesh_term>
    <mesh_term>Cholestasis, Extrahepatic</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03030573
org study id: Beaujon Hospital
nct id: NCT03030573
lead sponsor: 
has dmc: Yes
The investigators developed a new surgical technique in order to reconstruct the bile duct
      with the round ligament
Classically, the bile duct defect after bile duct injury or resection is achieved by
      bilioenteric reconstruction. However bilioenteric anastomosis is associated with long term
      complications including intrahepatic bile ducts infection, specific complications related to
      the Roux en Y jejunal loop and eliminate the endoscopic access to intrahepatic bile ducts.
      The investigators had recently developed a new surgical technique to reconstruct the veins
      with the parietal peritoneum with excellent results. Accordingly the investigators decided to
      develop a new surgical technique in order to reconstruct the bile duct defects with the
      vascularized round ligament.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Safety - absence of any severe complication or mortality related to the new procedure
time frame: at 1 year
description: Safety is defined by the absence of any severe complication (necrosis or biliary fistula) or mortality related to the new procedure.
measure: Bile buct patency
time frame: at 3 year
description: Secondary outcome include mainly the patency of the reconstructed bile duct.
arm group label: Device: Round ligament and the bile duct
arm group type: Other
description: The investigators describe the safety and efficacy of the reconstruction of the bile duct with the Round ligament.
intervention type: Procedure
intervention name: Reconstruction of the bile duct with the round ligament
description: In patients who had bile duct defect by injury or resection, the Round ligament will be used to reconstruct the defect. Surgical technique, the early and long term postoperative measures are detailed in the investigators protocol.
arm group label: Device: Round ligament and the bile duct
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Safi Dokmak, MD
role: Principal Investigator
affiliation: HBP department, Beaujon hospital, Clichy, France
last name: Safi Dokmak, MD
phone: 0033140875797
email: safi.dokmak@aphp.fr
facility: 
status: Recruiting
contact: 
investigator: 
country: France
responsible party type: Principal Investigator
investigator affiliation: Beaujon Hospital
investigator full name: Safi Dokmak
investigator title: MD
mesh term: Cholestasis
mesh term: Cholestasis, Extrahepatic
sharing ipd: No