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/NCT06039670</url>
    </required_header>
    <id_info>
      <org_study_id>PTFB</org_study_id>
      <nct_id>NCT06039670</nct_id>
    </id_info>
    <brief_title>Percutaneous Transluminal Forceps Biopsy</brief_title>
    <official_title>Percutaneous Transluminal Forceps Biopsy Combined With Transhepatic Biliary Drainage in the Management of Patients With Obstructive Jaundice: Efficacy, Safety and Accuracy</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University Hospital, Caen</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University Hospital, Caen</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>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        To evaluate during a 7 months period the efficacy, safety and accuracy of percutaneous&#xD;
        transluminal forceps biopsy combined with transhepatic biliary drainage in patients with&#xD;
        biliary stricture&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Biological parameters of liver function, histopathology of specimens, comparison with others&#xD;
        clinical and pathological data (imaging follow up, percutaneous biopsy, surgical biopsy,&#xD;
        endoscopic biopsy) were recorded Comparison between pathological findings of surgery or&#xD;
        endoscopy or percutaneous biopsy and specimens coming from biliary forceps biopsy follow up&#xD;
        of the patient 12 months after biopsy Evaluation of complications, accuracy&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">January 2, 2015</start_date>
    <completion_date type="Actual">August 31, 2016</completion_date>
    <primary_completion_date type="Actual">July 31, 2015</primary_completion_date>
    <study_type>Observational [Patient Registry]</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <target_duration>7 Months</target_duration>
    <primary_outcome>
      <measure>Efficacy of PTBD</measure>
      <time_frame>7 days</time_frame>
      <description>Efficacy of PTBD : bilirubinemia after PTFB at Day 7</description>
    </primary_outcome>
    <primary_outcome>
      <measure>accuracy for percutaneous biliary biopsy (PTFB)</measure>
      <time_frame>from baseline up to 1 month</time_frame>
      <description>Accuracy of PTFB : percentage of true positive and true negative results by pathologists</description>
    </primary_outcome>
    <primary_outcome>
      <measure>incidence of PTFB-related adverse events</measure>
      <time_frame>up to 1 month after procedure</time_frame>
      <description>Number of patients with PTFB related adverse-events as assessed by Society of Interventional Radiology Standards of Practice Committee classification</description>
    </primary_outcome>
    <enrollment type="Actual">50</enrollment>
    <condition>Biliary Stricture</condition>
    <condition>Biopsy Wound</condition>
    <condition>Oncology</condition>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>biliary biopsy</intervention_name>
      <description>biliary biopsy through a percutaneous approach during a percutaneous biliary drainage</description>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          patients with obstructive jaundice referred for percutaneous transhepatic biliary drainage&#xD;
          without histological diagnosis&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients with biliary strictures without histology available&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Pregnant patients&#xD;
  &#xD;
            -  Children&#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>Audrey Fohlen</last_name>
      <role>Principal Investigator</role>
      <affiliation>Caen UH</affiliation>
    </overall_official>
    <verification_date>June 2023</verification_date>
    <study_first_submitted>December 11, 2017</study_first_submitted>
    <study_first_submitted_qc>September 13, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 15, 2023</study_first_posted>
    <last_update_submitted>September 13, 2023</last_update_submitted>
    <last_update_submitted_qc>September 13, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Constriction, Pathologic</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</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/NCT06039670
  org study id: PTFB
  nct id: NCT06039670
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  To evaluate during a 7 months period the efficacy, safety and accuracy of percutaneous
        transluminal forceps biopsy combined with transhepatic biliary drainage in patients with
        biliary stricture
  Biological parameters of liver function, histopathology of specimens, comparison with others
        clinical and pathological data (imaging follow up, percutaneous biopsy, surgical biopsy,
        endoscopic biopsy) were recorded Comparison between pathological findings of surgery or
        endoscopy or percutaneous biopsy and specimens coming from biliary forceps biopsy follow up
        of the patient 12 months after biopsy Evaluation of complications, accuracy
  observational model: Cohort
  time perspective: Prospective
  measure: Efficacy of PTBD
  time frame: 7 days
  description: Efficacy of PTBD : bilirubinemia after PTFB at Day 7
  measure: accuracy for percutaneous biliary biopsy (PTFB)
  time frame: from baseline up to 1 month
  description: Accuracy of PTFB : percentage of true positive and true negative results by pathologists
  measure: incidence of PTFB-related adverse events
  time frame: up to 1 month after procedure
  description: Number of patients with PTFB related adverse-events as assessed by Society of Interventional Radiology Standards of Practice Committee classification
  intervention type: Procedure
  intervention name: biliary biopsy
  description: biliary biopsy through a percutaneous approach during a percutaneous biliary drainage
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Audrey Fohlen
  role: Principal Investigator
  affiliation: Caen UH
  responsible party type: Sponsor
  mesh term: Constriction, Pathologic
  sharing ipd: No