<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/NCT03805971</url>
  </required_header>
  <id_info>
    <org_study_id>B707201837069</org_study_id>
    <nct_id>NCT03805971</nct_id>
  </id_info>
  <brief_title>Probe Based Confocal Laser Endomicroscopy During Thoracoscopy for Pleural Malignancies Diagnosis.</brief_title>
  <official_title>Probe Based Confocal Laser Endomicroscopy During Thoracoscopy for Pleural Malignancies Diagnosis.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Liege</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Liege</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>
      Probe based confocal laser endomicroscopy (pCLE) is a new optical endoscopic technique,&#xD;
      generating fluorescent light emission from the tissue of interest and allowing in vivo live&#xD;
      imaging at a cellular level (&quot;optical biopsies&quot;). It was first used in gastroenterology and&#xD;
      came later to the light in pulmonary medicine and is still an experimental technique. In&#xD;
      gastroenterology, this new investigational technique is used in Barret oesophagus,&#xD;
      inflammatory bowel disease, pancreas cystic lesions... Nowadays, there are no data concerning&#xD;
      usefulness of endomicroscopy in medical thoracoscopy. During thoracoscopy This new tool could&#xD;
      help to target biopsies or help clinicians to do the right diagnosis early, allowing rapid&#xD;
      therapeutic intervention (talc pleurodesis for example) . Furthermore, some details can be&#xD;
      studied only during live imaging as microorganisms or bloodflows. The investigators performed&#xD;
      an endomicroscopy to every patient needing a thoracoscopy (no matter the indication) and who&#xD;
      agreed to participate. The pCLE features between malignant and benign pleura were compared in&#xD;
      order to find specific criteria for malignant infiltration.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 22, 2018</start_date>
  <completion_date type="Actual">December 1, 2019</completion_date>
  <primary_completion_date type="Actual">October 15, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Pleural Carcinomatosis Identification (Compared to Standard Biopsies). Qualitative Criteria.</measure>
    <time_frame>One day.</time_frame>
    <description>Eleven preselected criteria were assessed in their ability to distinguish benign from malignant pleura Qualitative variables are presented in this table</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pleural Carcinomatosis Identification (Compared to Standard Biopsies), Quantitative Criteria.</measure>
    <time_frame>One day</time_frame>
    <description>Eleven preselected pCLE criteria were assessed in their ability to distinguish benign from malignant pleura.&#xD;
Here are presented Mean cell size and maximum vascular diameter</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pleural Carcinomatosis Identification (Compared to Standard Biopsies), Quantitative Criteria.</measure>
    <time_frame>One day</time_frame>
    <description>Eleven preselected pCLE criteria were assessed in their ability to distinguish benign from malignant pleura.&#xD;
Quantitative criteria are presented in this table. Here is presented the mean cellular density</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pleural Carcinomatosis Identification (Compared to Standard Biopsies), Quantitative Criteria.</measure>
    <time_frame>One day</time_frame>
    <description>Eleven preselected pCLE criteria were assessed in their ability to distinguish benign from malignant pleura.&#xD;
Quantitative criteria are presented in this table. Here is presented the vascular density.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quality of the pCLE Acquisition</measure>
    <time_frame>One day</time_frame>
    <description>The investigators performing the thoracoscopy had to score the pCLE acquisition. Three level of quality were used: Good, Acceptable, Low.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">65</enrollment>
  <condition>Pleural Carcinomatosis</condition>
  <arm_group>
    <arm_group_label>patient aged more than 18 years admitted for thoracoscopy</arm_group_label>
    <description>Probe based confocal laser endomicroscopy (Mauna kea technologies) will be used, after intravenous fluorescein injection, for every patients admitted for medical thoracoscopy, to study the pleural cavity. Images will be compared with biopsies</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Study of the pleural cavity with a confocal laser endomicroscope.</intervention_name>
    <description>Probe based confocal laser endomicroscope can be introduced through the working chanel of the thoracoscope. this allows the study of the pleural cavity with this new tool.</description>
    <arm_group_label>patient aged more than 18 years admitted for thoracoscopy</arm_group_label>
  </intervention>
  <biospec_retention>None Retained</biospec_retention>
  <biospec_descr>
    <textblock>
      Pleural biopsies.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Every patient refered for a medical thoracoscopy and willing to participate.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Every patient refered for a medical thoracoscopy and willing to participate.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  &lt; 18 ans&#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>Olivier Bonhomme, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHU de Liège</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CHU de Liège</name>
      <address>
        <city>Liège</city>
        <zip>4000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>January 13, 2019</study_first_submitted>
  <study_first_submitted_qc>January 15, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 16, 2019</study_first_posted>
  <results_first_submitted>December 2, 2019</results_first_submitted>
  <results_first_submitted_qc>March 21, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">April 3, 2020</results_first_posted>
  <last_update_submitted>March 21, 2020</last_update_submitted>
  <last_update_submitted_qc>March 21, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">April 3, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Liege</investigator_affiliation>
    <investigator_full_name>Olivier Bonhomme</investigator_full_name>
    <investigator_title>Medical doctor - clinical assistant</investigator_title>
  </responsible_party>
  <keyword>pCLE</keyword>
  <keyword>confocal laser endomicroscopy</keyword>
  <keyword>pleural carcinomatosis</keyword>
  <keyword>mesothelioma</keyword>
  <keyword>optical biopsies</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>December 2, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/71/NCT03805971/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Patient Aged More Than 18 Years Admitted for Thoracoscopy</title>
          <description>Probe based confocal laser endomicroscopy (Mauna kea technologies) will be used, after intravenous fluorescein injection, for every patients admitted for medical thoracoscopy, to study the pleural cavity. Images will be compared with biopsies&#xD;
Study of the pleural cavity with a confocal laser endomicroscope.: Probe based confocal laser endomicroscope can be introduced through the working chanel of the thoracoscope. this allows the study of the pleural cavity with this new tool.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="65"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="62"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Patient Aged More Than 18 Years Admitted for Thoracoscopy</title>
          <description>Probe based confocal laser endomicroscopy (Mauna kea technologies) will be used, after intravenous fluorescein injection, for every patients admitted for medical thoracoscopy, to study the pleural cavity. Images will be compared with biopsies&#xD;
Study of the pleural cavity with a confocal laser endomicroscope.: Probe based confocal laser endomicroscope can be introduced through the working chanel of the thoracoscope. this allows the study of the pleural cavity with this new tool.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="62"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="62"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="64.4" spread="17.29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <description>Gender ratio</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="62"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Thoracoscopy indication</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="62"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Talc pleurodesis for recurrent pneumothorax</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Pleural exudation management (mainly lymphocytic)</title>
                  <measurement_list>
                    <measurement group_id="B1" value="46"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Talc pleurodesis for recurrent malignant effusion</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Pleural hyper metabolism on TEP</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Pleural nodularity on CT-scan</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Final histological diagnosis</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="62"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Normal pleura</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>(Sub-)acute pleuritis</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Chronic pleuritis</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Pulmonary adenocarcinoma</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Malignant mesothelioma</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Large cell lymphoma</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Small cell lung carcinoma</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Squamous cell lung carcinoma</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Breast adenocarcinoma</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Urothelial Carcinoma</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Sarcoidosi</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Pleural Carcinomatosis Identification (Compared to Standard Biopsies). Qualitative Criteria.</title>
        <description>Eleven preselected criteria were assessed in their ability to distinguish benign from malignant pleura Qualitative variables are presented in this table</description>
        <time_frame>One day.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Benign Pleura</title>
            <description>Participants with a benign pleura histological diagnosis.</description>
          </group>
          <group group_id="O2">
            <title>Malignant Pleural Infiltrations</title>
            <description>Participants with a malignant pleural disease demonstrated by biopsies.</description>
          </group>
        </group_list>
        <measure>
          <title>Pleural Carcinomatosis Identification (Compared to Standard Biopsies). Qualitative Criteria.</title>
          <description>Eleven preselected criteria were assessed in their ability to distinguish benign from malignant pleura Qualitative variables are presented in this table</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="36"/>
                <count group_id="O2" value="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Abnormal tissular architecture</title>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="24"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="21"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not assessable</title>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cellular size homogeneity</title>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="18"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                    <measurement group_id="O2" value="16"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not assessable</title>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cellular shape homogeneity</title>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="18"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                    <measurement group_id="O2" value="19"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not assessable</title>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cellular fluorescence homogeneity</title>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="28"/>
                    <measurement group_id="O2" value="14"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not assessable</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Blood vessels dysplasia</title>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="17"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="23"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not assessable</title>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Organized connective tissue</title>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="20"/>
                    <measurement group_id="O2" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not assessable</title>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Chia seed sign</title>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="23"/>
                    <measurement group_id="O2" value="26"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not assessable</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The objective of the test is to assess if the pCLE feature &quot;full chia seed sign&quot; is found statistically more frequently in the &quot;benign pleura group&quot; than in the &quot;malignant pleural infiltrations group&quot;.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0003</p_value>
            <method>Fisher Exact</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The objective is to assess if the abnormal tissular architecture is significantly more frequently found in the &quot;malignant pleural infiltrations group&quot; than in the &quot;benign pleura group&quot;.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>Fisher Exact</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The objective is to assess if the pCLE feature &quot;cellular shape homogeneity&quot; is found statistically more frequently in the &quot;benign pleura group&quot; than in the &quot;malignant pleural infiltrations group&quot;.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0052</p_value>
            <method>Fisher Exact</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The objective is to assess if dysplastic vessels are more frequently found in the &quot;malignant pleural infiltrations group&quot; than in the &quot;benign pleura group&quot;.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>Fisher Exact</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Pleural Carcinomatosis Identification (Compared to Standard Biopsies), Quantitative Criteria.</title>
        <description>Eleven preselected pCLE criteria were assessed in their ability to distinguish benign from malignant pleura.&#xD;
Here are presented Mean cell size and maximum vascular diameter</description>
        <time_frame>One day</time_frame>
        <population>Some criteria were not assessable for some patients.</population>
        <group_list>
          <group group_id="O1">
            <title>Benign Pleura</title>
            <description>Participants with a benign pleura histological diagnosis.</description>
          </group>
          <group group_id="O2">
            <title>Malignant Pleural Infiltrations</title>
            <description>Participants with a malignant pleural disease demonstrated by biopsies.</description>
          </group>
        </group_list>
        <measure>
          <title>Pleural Carcinomatosis Identification (Compared to Standard Biopsies), Quantitative Criteria.</title>
          <description>Eleven preselected pCLE criteria were assessed in their ability to distinguish benign from malignant pleura.&#xD;
Here are presented Mean cell size and maximum vascular diameter</description>
          <population>Some criteria were not assessable for some patients.</population>
          <units>µm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="36"/>
                <count group_id="O2" value="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Mean cell size</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="29"/>
                    <count group_id="O2" value="23"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.76" spread="5.69"/>
                    <measurement group_id="O2" value="22.96" spread="5.16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Maximal vascular diameter</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="27"/>
                    <count group_id="O2" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.72" spread="9.93"/>
                    <measurement group_id="O2" value="27.08" spread="8.91"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Quality of the pCLE Acquisition</title>
        <description>The investigators performing the thoracoscopy had to score the pCLE acquisition. Three level of quality were used: Good, Acceptable, Low.</description>
        <time_frame>One day</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Benign Pleura</title>
            <description>Participants with a benign pleura histological diagnosis.</description>
          </group>
          <group group_id="O2">
            <title>Malignant Pleural Infiltrations</title>
            <description>Participants with a malignant pleural disease demonstrated by biopsies.</description>
          </group>
        </group_list>
        <measure>
          <title>Quality of the pCLE Acquisition</title>
          <description>The investigators performing the thoracoscopy had to score the pCLE acquisition. Three level of quality were used: Good, Acceptable, Low.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="36"/>
                <count group_id="O2" value="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Good</title>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Acceptable</title>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                    <measurement group_id="O2" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Low</title>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Pleural Carcinomatosis Identification (Compared to Standard Biopsies), Quantitative Criteria.</title>
        <description>Eleven preselected pCLE criteria were assessed in their ability to distinguish benign from malignant pleura.&#xD;
Quantitative criteria are presented in this table. Here is presented the mean cellular density</description>
        <time_frame>One day</time_frame>
        <population>Some criteria were not assessable for some patients.</population>
        <group_list>
          <group group_id="O1">
            <title>Benign Pleura</title>
            <description>Participants with a benign pleura histological diagnosis.</description>
          </group>
          <group group_id="O2">
            <title>Malignant Pleural Infiltrations</title>
            <description>Participants with a malignant pleural disease demonstrated by biopsies.</description>
          </group>
        </group_list>
        <measure>
          <title>Pleural Carcinomatosis Identification (Compared to Standard Biopsies), Quantitative Criteria.</title>
          <description>Eleven preselected pCLE criteria were assessed in their ability to distinguish benign from malignant pleura.&#xD;
Quantitative criteria are presented in this table. Here is presented the mean cellular density</description>
          <population>Some criteria were not assessable for some patients.</population>
          <units>number of cells/10^4µm^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="36"/>
                <count group_id="O2" value="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25.42" spread="8.73"/>
                    <measurement group_id="O2" value="22.01" spread="7.35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Pleural Carcinomatosis Identification (Compared to Standard Biopsies), Quantitative Criteria.</title>
        <description>Eleven preselected pCLE criteria were assessed in their ability to distinguish benign from malignant pleura.&#xD;
Quantitative criteria are presented in this table. Here is presented the vascular density.</description>
        <time_frame>One day</time_frame>
        <population>Some criteria were not assessable for some patients.</population>
        <group_list>
          <group group_id="O1">
            <title>Benign Pleura</title>
            <description>Participants with a benign pleura histological diagnosis.</description>
          </group>
          <group group_id="O2">
            <title>Malignant Pleural Infiltrations</title>
            <description>Participants with a malignant pleural disease demonstrated by biopsies.</description>
          </group>
        </group_list>
        <measure>
          <title>Pleural Carcinomatosis Identification (Compared to Standard Biopsies), Quantitative Criteria.</title>
          <description>Eleven preselected pCLE criteria were assessed in their ability to distinguish benign from malignant pleura.&#xD;
Quantitative criteria are presented in this table. Here is presented the vascular density.</description>
          <population>Some criteria were not assessable for some patients.</population>
          <units>Vessels/1.13 mm^2 (full optic area)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="36"/>
                <count group_id="O2" value="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.81" spread="7.73"/>
                    <measurement group_id="O2" value="6.9" spread="2.53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>1 day</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Patient Aged More Than 18 Years Admitted for Thoracoscopy</title>
          <description>Probe based confocal laser endomicroscopy (Mauna kea technologies) will be used, after intravenous fluorescein injection, for every patients admitted for medical thoracoscopy, to study the pleural cavity. Images will be compared with biopsies&#xD;
Study of the pleural cavity with a confocal laser endomicroscope.: Probe based confocal laser endomicroscope can be introduced through the working chanel of the thoracoscope. this allows the study of the pleural cavity with this new tool.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="62"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>1</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="62"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr Olivier Bonhomme</name_or_title>
      <organization>Centre hospitalier universitaire de Liège</organization>
      <phone>003243667881</phone>
      <email>obonhomme@chuliege.be</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03805971
org study id: B707201837069
nct id: NCT03805971
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Probe based confocal laser endomicroscopy (pCLE) is a new optical endoscopic technique,
      generating fluorescent light emission from the tissue of interest and allowing in vivo live
      imaging at a cellular level ("optical biopsies"). It was first used in gastroenterology and
      came later to the light in pulmonary medicine and is still an experimental technique. In
      gastroenterology, this new investigational technique is used in Barret oesophagus,
      inflammatory bowel disease, pancreas cystic lesions... Nowadays, there are no data concerning
      usefulness of endomicroscopy in medical thoracoscopy. During thoracoscopy This new tool could
      help to target biopsies or help clinicians to do the right diagnosis early, allowing rapid
      therapeutic intervention (talc pleurodesis for example) . Furthermore, some details can be
      studied only during live imaging as microorganisms or bloodflows. The investigators performed
      an endomicroscopy to every patient needing a thoracoscopy (no matter the indication) and who
      agreed to participate. The pCLE features between malignant and benign pleura were compared in
      order to find specific criteria for malignant infiltration.
observational model: Case-Only
time perspective: Prospective
measure: Pleural Carcinomatosis Identification (Compared to Standard Biopsies). Qualitative Criteria.
time frame: One day.
description: Eleven preselected criteria were assessed in their ability to distinguish benign from malignant pleura Qualitative variables are presented in this table
measure: Pleural Carcinomatosis Identification (Compared to Standard Biopsies), Quantitative Criteria.
time frame: One day
description: Eleven preselected pCLE criteria were assessed in their ability to distinguish benign from malignant pleura.
Here are presented Mean cell size and maximum vascular diameter
measure: Pleural Carcinomatosis Identification (Compared to Standard Biopsies), Quantitative Criteria.
time frame: One day
description: Eleven preselected pCLE criteria were assessed in their ability to distinguish benign from malignant pleura.
Quantitative criteria are presented in this table. Here is presented the mean cellular density
measure: Pleural Carcinomatosis Identification (Compared to Standard Biopsies), Quantitative Criteria.
time frame: One day
description: Eleven preselected pCLE criteria were assessed in their ability to distinguish benign from malignant pleura.
Quantitative criteria are presented in this table. Here is presented the vascular density.
measure: Quality of the pCLE Acquisition
time frame: One day
description: The investigators performing the thoracoscopy had to score the pCLE acquisition. Three level of quality were used: Good, Acceptable, Low.
arm group label: patient aged more than 18 years admitted for thoracoscopy
description: Probe based confocal laser endomicroscopy (Mauna kea technologies) will be used, after intravenous fluorescein injection, for every patients admitted for medical thoracoscopy, to study the pleural cavity. Images will be compared with biopsies
intervention type: Device
intervention name: Study of the pleural cavity with a confocal laser endomicroscope.
description: Probe based confocal laser endomicroscope can be introduced through the working chanel of the thoracoscope. this allows the study of the pleural cavity with this new tool.
arm group label: patient aged more than 18 years admitted for thoracoscopy
Pleural biopsies.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Olivier Bonhomme, MD
role: Principal Investigator
affiliation: CHU de Liège
facility: 
country: Belgium
responsible party type: Principal Investigator
investigator affiliation: University of Liege
investigator full name: Olivier Bonhomme
investigator title: Medical doctor - clinical assistant
mesh term: Carcinoma
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 