<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/NCT04405752</url>
  </required_header>
  <id_info>
    <org_study_id>BIGDIAM-IPC 2018-056</org_study_id>
    <nct_id>NCT04405752</nct_id>
  </id_info>
  <brief_title>Evaluation of a New Metal Biliary Stent of 12-mm Diameter: a Case Control Study</brief_title>
  <acronym>BIGDIAM</acronym>
  <official_title>Evaluation of a New Metal Biliary Stent of 12-mm Diameter: a Case Control Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Institut Paoli-Calmettes</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Institut Paoli-Calmettes</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>
      Biliary stent allows the drainage of the bile ducts palliatively or preoperatively in the&#xD;
      event of malignant biliary stenosis, and a biliary calibration in the event of benign&#xD;
      stenosis. Currently, by expert agreement, the diameter is 10-mm for metal stent. Since 2017,&#xD;
      larger stents have been marketed in France and are approved for the biliary drainage of&#xD;
      benign and malignant biliary stricture. These new 12-mm diameter stent could reduce the risk&#xD;
      of recurrent biliary obstruction (RBO) and therefore increase the stent duration. The aim of&#xD;
      our study was to compare whether the permeability of 12-mm diameter stent was better than a&#xD;
      conventional 10-mm, covered or uncovered prosthesis depending on the indication.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 1, 2017</start_date>
  <completion_date type="Actual">April 1, 2018</completion_date>
  <primary_completion_date type="Actual">April 1, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Time to recurrent biliary obstruction (RBO)</measure>
    <time_frame>12 months</time_frame>
    <description>RBO is defined as the time from the prosthesis deployment to until the first biliary stent obstruction (patency</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">72</enrollment>
  <condition>Malignant Biliary Obstruction</condition>
  <arm_group>
    <arm_group_label>12-mm diameter metallic billiary stent</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>10-mm diameter metallic billiary stent</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>12-mm metallic biliary stent</intervention_name>
    <description>Metallic biliary stent, covered or uncovered,KEBOMED HILZO 12mm in diameter (length 4 or 6 cm).</description>
    <arm_group_label>12-mm diameter metallic billiary stent</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>10-mm metallic biliary stent</intervention_name>
    <description>Biliary, metallic, covered or uncovered stent, COOK EVOLUTION 10mm in diameter (length 4 or 6 cm)</description>
    <arm_group_label>10-mm diameter metallic billiary stent</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        From April 2017 to April 2018, at the Paoli Calmettes Institute, 24 patients with benign or&#xD;
        malignant biliary strictures were treated by placing a metallic biliary stent, covered or&#xD;
        uncovered, KEBOMED HILZO 12mm in diameter (length 4 or 6 cm).&#xD;
&#xD;
        &quot;Control&quot; patients, who had benefited from the placement of a biliary, metallic, covered or&#xD;
        uncovered stent, COOK EVOLUTION 10mm in diameter (length 4 or 6 cm) were searched on a&#xD;
        database (ConsortConsore®️)extending from January 2016 to March 2018. &quot;Cases&quot; patients were&#xD;
        exactly matched in a ratio 1:2 to &quot;control&quot; on the following criteria: age (per decade),&#xD;
        sex, pathology responsible for biliary stenosis (i.e., benign or malignant stenosis) and&#xD;
        type of stent (i.e., covered/uncovered). When we searched for control patients in our&#xD;
        database, the first patient with matching criteria was included.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  benign and malignant biliary stricture of the lower or median portion of the main&#xD;
             biliary duct with indication of biliary stent placement including pre-operatively&#xD;
             drainage&#xD;
&#xD;
          -  age≥ 18 years old;&#xD;
&#xD;
          -  Karnofsky score ≥ 40.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  hilar stenosis;&#xD;
&#xD;
          -  coagulation disorder (PT &lt;50%, platelets &lt; 80,000).&#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>Fabrice Caillol</last_name>
    <role>Principal Investigator</role>
    <affiliation>Institut Paoli-Calmettes</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Institut Paoli Calmettes</name>
      <address>
        <city>Marseille</city>
        <state>Bouches Du Rhône</state>
        <zip>13273</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 22, 2020</study_first_submitted>
  <study_first_submitted_qc>May 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 28, 2020</study_first_posted>
  <last_update_submitted>May 22, 2020</last_update_submitted>
  <last_update_submitted_qc>May 22, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 28, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>biliary stent</keyword>
  <keyword>malignant biliary stenosis</keyword>
  <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/NCT04405752
org study id: BIGDIAM-IPC 2018-056
nct id: NCT04405752
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Biliary stent allows the drainage of the bile ducts palliatively or preoperatively in the
      event of malignant biliary stenosis, and a biliary calibration in the event of benign
      stenosis. Currently, by expert agreement, the diameter is 10-mm for metal stent. Since 2017,
      larger stents have been marketed in France and are approved for the biliary drainage of
      benign and malignant biliary stricture. These new 12-mm diameter stent could reduce the risk
      of recurrent biliary obstruction (RBO) and therefore increase the stent duration. The aim of
      our study was to compare whether the permeability of 12-mm diameter stent was better than a
      conventional 10-mm, covered or uncovered prosthesis depending on the indication.
observational model: Case-Control
time perspective: Retrospective
measure: Time to recurrent biliary obstruction (RBO)
time frame: 12 months
description: RBO is defined as the time from the prosthesis deployment to until the first biliary stent obstruction (patency
arm group label: 12-mm diameter metallic billiary stent
arm group label: 10-mm diameter metallic billiary stent
intervention type: Device
intervention name: 12-mm metallic biliary stent
description: Metallic biliary stent, covered or uncovered,KEBOMED HILZO 12mm in diameter (length 4 or 6 cm).
arm group label: 12-mm diameter metallic billiary stent
intervention type: Device
intervention name: 10-mm metallic biliary stent
description: Biliary, metallic, covered or uncovered stent, COOK EVOLUTION 10mm in diameter (length 4 or 6 cm)
arm group label: 10-mm diameter metallic billiary stent
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Fabrice Caillol
role: Principal Investigator
affiliation: Institut Paoli-Calmettes
facility: 
country: France
responsible party type: Sponsor
sharing ipd: No