<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/NCT02970175</url>
  </required_header>
  <id_info>
    <org_study_id>2014/212/HP</org_study_id>
    <nct_id>NCT02970175</nct_id>
  </id_info>
  <brief_title>Interest of in Situ Terlipressin Administration Before the Realisation of Bronchial Biopsy</brief_title>
  <acronym>TERLAB</acronym>
  <official_title>Interest of in Situ Terlipressin Administration Before the Realisation of Bronchial Biopsy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Rouen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Rouen</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>
      The diagnostic yield of flexible bronchoscopy for the diagnosis of lung cancer depends on the&#xD;
      location and the histological type of the lesion, as well as on the number of biopsy samples&#xD;
      performed. The increasing number of sampling is also important to provide material for&#xD;
      molecular assessment of lung cancer. The French National Institute for Cancer recommends a&#xD;
      number of 5 biopsies in order to reach a diagnostic yield of 88%. However, as increasing the&#xD;
      number of bronchial biopsies comes with a higher risk of bleeding, the management of&#xD;
      endobronchial bleeding may be determinant for the diagnostic yield.&#xD;
&#xD;
      The most recent recommendations of the British Thoracic Society for the management of&#xD;
      bronchial bleeding, after bronchial or transbronchial biopsy, are to inject 5 to 10 mL of&#xD;
      1/10000 diluted adrenalin, or cold saline serum (04°C.). The French guidelines also include&#xD;
      the use of endobronchial terlipressin, which has local vasoconstriction effect. After&#xD;
      endobronchial administration of terlipressin, plasmatic concentrations are low, and are not&#xD;
      clinically relevant.&#xD;
&#xD;
      The hypothesis of this clinical trial is that endobronchial instillation of terlipressin&#xD;
      before sampling endobronchial tumor will limit the endobronchial bleeding and allow to&#xD;
      increase the number of biopsies performed and, eventually, the diagnostic yield.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 30, 2017</start_date>
  <completion_date type="Anticipated">February 2020</completion_date>
  <primary_completion_date type="Anticipated">February 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>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of biopsy realized during the endoscopy</measure>
    <time_frame>Day 1</time_frame>
    <description>The number of biopsy by endoscopy realized into each group will be calculated</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of biopsy allowing an histological diagnosis</measure>
    <time_frame>Day 1</time_frame>
    <description>The number of biopsy allowing an histological diagnosis into each group will be calculated</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of adverse events due to terlipressin administration</measure>
    <time_frame>Day 1</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">130</enrollment>
  <condition>Bronchial Endoscopy</condition>
  <arm_group>
    <arm_group_label>Bronchoscopy with terlipressin administration</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients undergoing a bronchoscopy under local anesthesia for biopsy sampling of endobronchial lesions. Bronchoscopy will be done with terlipressin administration</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Bronchoscopy without terlipressin administration</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Patients undergoing a bronchoscopy under local anesthesia for biopsy sampling of endobronchial lesions. Bronchoscopy will be done without terlipressin administration</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Terlipressin administration</intervention_name>
    <description>Patients undergoing a bronchoscopy under local anesthesia for biopsy sampling of endobronchial lesions. Bronchoscopy will be done with terlipressin administration</description>
    <arm_group_label>Bronchoscopy with terlipressin administration</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>bronchoscopy under local anesthesia</intervention_name>
    <description>Patients undergoing a bronchoscopy under local anesthesia for biopsy sampling of endobronchial lesions. Bronchoscopy will be done with terlipressin administration</description>
    <arm_group_label>Bronchoscopy with terlipressin administration</arm_group_label>
    <arm_group_label>Bronchoscopy without terlipressin administration</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Biopsy sampling</intervention_name>
    <description>Patients undergoing a bronchoscopy under local anesthesia for biopsy sampling of endobronchial lesions. Bronchoscopy will be done with terlipressin administration</description>
    <arm_group_label>Bronchoscopy with terlipressin administration</arm_group_label>
    <arm_group_label>Bronchoscopy without terlipressin administration</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients ≥18 years old&#xD;
&#xD;
          -  Patients scheduled to undergo bronchoscopy, presenting a suspicious radiographic&#xD;
             lesion and a lesion proximal tumor pace viewable in white light endoscopy and without&#xD;
             pathologic diagnosis&#xD;
&#xD;
          -  Patient having read and understood the information letter and signed the consent form&#xD;
&#xD;
          -  Effective contraception in women of childbearing age&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with contraindication to the use of terlipressin:&#xD;
&#xD;
          -  septic shock ,&#xD;
&#xD;
          -  Hypersensitivity to terlipressin or the excipients or by whom use the product is not&#xD;
             recommended:&#xD;
&#xD;
          -  Recent history (&lt;3 months) of acute coronary syndrome (including myocardial&#xD;
             infarction) or unbalanced coronary insufficiency, or disorders of the ventricular&#xD;
             heart rate.&#xD;
&#xD;
          -  severe uncontrolled hypertension,&#xD;
&#xD;
          -  cerebrovascular insufficiency and ischemic stroke of recent origin (&lt;3 months).&#xD;
&#xD;
          -  severe arterial occlusive lower extremities,&#xD;
&#xD;
          -  severe chronic renal impairment (GFR &lt;20 ml / min).&#xD;
&#xD;
          -  Patients receiving uninterrupted antiplatelet therapy during 5 days before endoscopy&#xD;
             (7 days for Clopidogrel Related), including low dose aspirin (≤ 75 mg / day).&#xD;
&#xD;
          -  Patients receiving anticoagulant therapy:&#xD;
&#xD;
          -  Unfractionated heparin within 12 hours before endoscopy.&#xD;
&#xD;
          -  low molecular weight heparin within 24 hours before endoscopy.&#xD;
&#xD;
          -  Patients with bleeding disorders defined by TP below 70% or TCA ratio patient /&#xD;
             control greater than 1.3.&#xD;
&#xD;
          -  Patients with thrombocytopenia less than 100 g / L.&#xD;
&#xD;
          -  Subjects misunderstanding of spoken and written French&#xD;
&#xD;
          -  Person under guardianship or deprived of liberty by judicial or administrative&#xD;
             decision (under Article L1121-6 and L1121-8 of Public Health Code&#xD;
&#xD;
          -  Pregnant or lactating women, premenopausal women without adequate contraception&#xD;
&#xD;
          -  Patient participating in other drug testing or participating in another drug test in&#xD;
             the previous month&#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>Mathieu SALAUN, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Rouen University Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Mathieu SALAUN, MD</last_name>
    <phone>+3323288</phone>
    <phone_ext>8265</phone_ext>
    <email>mathieu.salaun@chu-rouen.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Julien BLOT</last_name>
    <email>julien.blot@chu-rouen.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Rouen University Hospital</name>
      <address>
        <city>Rouen</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mathieu SALAUN, MD</last_name>
    </contact>
    <investigator>
      <last_name>Mathieu SALAUN, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Luc THIBERVILLE, Pr</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>May 2018</verification_date>
  <study_first_submitted>November 18, 2016</study_first_submitted>
  <study_first_submitted_qc>November 18, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 21, 2016</study_first_posted>
  <last_update_submitted>May 25, 2018</last_update_submitted>
  <last_update_submitted_qc>May 25, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">May 30, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Terlipressin</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Terlipressin</mesh_term>
  </intervention_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/NCT02970175
org study id: 2014/212/HP
nct id: NCT02970175
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The diagnostic yield of flexible bronchoscopy for the diagnosis of lung cancer depends on the
      location and the histological type of the lesion, as well as on the number of biopsy samples
      performed. The increasing number of sampling is also important to provide material for
      molecular assessment of lung cancer. The French National Institute for Cancer recommends a
      number of 5 biopsies in order to reach a diagnostic yield of 88%. However, as increasing the
      number of bronchial biopsies comes with a higher risk of bleeding, the management of
      endobronchial bleeding may be determinant for the diagnostic yield.

      The most recent recommendations of the British Thoracic Society for the management of
      bronchial bleeding, after bronchial or transbronchial biopsy, are to inject 5 to 10 mL of
      1/10000 diluted adrenalin, or cold saline serum (04°C.). The French guidelines also include
      the use of endobronchial terlipressin, which has local vasoconstriction effect. After
      endobronchial administration of terlipressin, plasmatic concentrations are low, and are not
      clinically relevant.

      The hypothesis of this clinical trial is that endobronchial instillation of terlipressin
      before sampling endobronchial tumor will limit the endobronchial bleeding and allow to
      increase the number of biopsies performed and, eventually, the diagnostic yield.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Participant, Investigator)
measure: Number of biopsy realized during the endoscopy
time frame: Day 1
description: The number of biopsy by endoscopy realized into each group will be calculated
measure: Number of biopsy allowing an histological diagnosis
time frame: Day 1
description: The number of biopsy allowing an histological diagnosis into each group will be calculated
measure: Number of adverse events due to terlipressin administration
time frame: Day 1
arm group label: Bronchoscopy with terlipressin administration
arm group type: Experimental
description: Patients undergoing a bronchoscopy under local anesthesia for biopsy sampling of endobronchial lesions. Bronchoscopy will be done with terlipressin administration
arm group label: Bronchoscopy without terlipressin administration
arm group type: Placebo Comparator
description: Patients undergoing a bronchoscopy under local anesthesia for biopsy sampling of endobronchial lesions. Bronchoscopy will be done without terlipressin administration
intervention type: Drug
intervention name: Terlipressin administration
description: Patients undergoing a bronchoscopy under local anesthesia for biopsy sampling of endobronchial lesions. Bronchoscopy will be done with terlipressin administration
arm group label: Bronchoscopy with terlipressin administration
intervention type: Procedure
intervention name: bronchoscopy under local anesthesia
description: Patients undergoing a bronchoscopy under local anesthesia for biopsy sampling of endobronchial lesions. Bronchoscopy will be done with terlipressin administration
arm group label: Bronchoscopy with terlipressin administration
arm group label: Bronchoscopy without terlipressin administration
intervention type: Procedure
intervention name: Biopsy sampling
description: Patients undergoing a bronchoscopy under local anesthesia for biopsy sampling of endobronchial lesions. Bronchoscopy will be done with terlipressin administration
arm group label: Bronchoscopy with terlipressin administration
arm group label: Bronchoscopy without terlipressin administration
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Mathieu SALAUN, MD
role: Principal Investigator
affiliation: Rouen University Hospital
last name: Mathieu SALAUN, MD
phone: +3323288
phone ext: 8265
email: mathieu.salaun@chu-rouen.fr
last name: Julien BLOT
email: julien.blot@chu-rouen.fr
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
country: France
responsible party type: Sponsor
mesh term: Terlipressin
sharing ipd: No