<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/NCT03272087</url>
  </required_header>
  <id_info>
    <org_study_id>Resp-REPEAT-SIRE-2</org_study_id>
    <nct_id>NCT03272087</nct_id>
  </id_info>
  <brief_title>Rational Approach to a Unilateral Pleural Effusion</brief_title>
  <acronym>REPEAT</acronym>
  <official_title>Rational Approach to Unilateral Pleural Effusion in Patients Suspected of Malignancy. Efficacy, Pain, Quality of Life, and Economy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Naestved Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Southern Denmark</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Odense University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Zealand University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University Hospital, Gentofte, Copenhagen</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Bispebjerg Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Rigshospitalet, Denmark</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Naestved Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Recurrent unilateral, non-infectious pleural exudate is suspicious for primary or secondary&#xD;
      pleural malignancy. Both conditions are associated with 5-year survival of 10%. Work-up is&#xD;
      difficult, as the pleural surface is large and &lt;33% of pleural malignancies shed malignant&#xD;
      cells to the pleural fluid. Even so, additional tissue biopsies are needed for establishing&#xD;
      mutation status for targeted therapies.&#xD;
&#xD;
      Optimal imaging to guide tissue sampling is pivotal. PET-CT has higher sensitivity than&#xD;
      conventional CT for detecting malignant lesions &gt;10mm. However, no randomised trial has&#xD;
      investigated differences in diagnostic accuracy, time-to-diagnosis, or economics. Falsely&#xD;
      PET-positive lesions in e.g. colon, however, lead to more derived tests than do CT alone.&#xD;
&#xD;
      Gold standard for pleural tissue sampling is the surgical (VATS) thoracoscopy, allowing&#xD;
      direct visual guiding of tissue sampling from all pleural surfaces. Yet, globally the medical&#xD;
      (pleuroscopy) thoracoscopy is more widely used: cheaper, outpatient procedure, but allows&#xD;
      only sampling from the parietal pleura. To date, no randomised studies have compared medical&#xD;
      and surgical thoracoscopy concerning diagnostic hit rates, adverse events, or economics.&#xD;
&#xD;
      Investigators will perform two randomized studies to investigate whether&#xD;
&#xD;
        1. PET/CT is comparable to CT alone&#xD;
&#xD;
        2. VATS is comparable to pleuroscopy concerning hit rate, total investigations performed,&#xD;
           time-to-diagnosis.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Patient inclusion cannot be completed within time limits&#xD;
  </why_stopped>
  <start_date type="Actual">May 2015</start_date>
  <completion_date type="Actual">December 15, 2020</completion_date>
  <primary_completion_date type="Actual">December 15, 2020</primary_completion_date>
  <phase>N/A</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>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of patients diagnosed with cancer</measure>
    <time_frame>2 years</time_frame>
    <description>(cancer = an unequivocal diagnosis of neoplastic disease; no cancer = clinically benign cause, and improved imaging at 6 month control).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quality of life</measure>
    <time_frame>1 month</time_frame>
    <description>Questionnaire developed to assess the quality of life of cancer patients, QLQC 30</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total costs</measure>
    <time_frame>2 years</time_frame>
    <description>calculated as costs patient-related, procedure-related, and overall</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain</measure>
    <time_frame>2 years</time_frame>
    <description>VAS scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life</measure>
    <time_frame>1 month</time_frame>
    <description>A standardised instrument for use as a measure of health outcome, EuroQol EQ-5D</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">120</enrollment>
  <condition>Lung Neoplasms</condition>
  <arm_group>
    <arm_group_label>Pleuroscopy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>According to BTS guideline thoracoscopy is the next procedure for patients who remain undiagnosed despite PET-CT and attempts to obtain biopsies. Eligible patients will be randomised to pleuroscopy or VATS. Patients with inconclusive pleuroscopy will proceed to VATS.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>VATS (thoracoscopy)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>According to BTS guideline thoracoscopy is the next procedure for patients who remain undiagnosed despite PET-CT and attempts to obtain biopsies. Eligible patients will be randomised to pleuroscopy or VATS. Patients with inconclusive pleuroscopy will proceed to VATS.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Thoracoscopy</intervention_name>
    <description>50 % of patients will have performed af medical thoracoscopy (pleuroscopy)</description>
    <arm_group_label>Pleuroscopy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>VATS (thoracoscopy)</intervention_name>
    <description>50 % of patients will have performed a VATS (video-assisted thoracic surgery) thoracoscopy</description>
    <arm_group_label>VATS (thoracoscopy)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients with recurrent pleural effusion of unknown origin after a first pleural tap&#xD;
             according to BTS guidelines.&#xD;
&#xD;
          2. Indication for thoracoscopy according to BTS guidelines.&#xD;
&#xD;
          3. Patients accept further investigation according to Danish and BTS guidelines.&#xD;
&#xD;
          4. Have received oral and written consent and agreed.&#xD;
&#xD;
          5. At the time of inclusion, above 18 years of age.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Female patients: pregnancy or breastfeeding.&#xD;
&#xD;
          2. Lack of language comprehension.&#xD;
&#xD;
          3. Legally incompetent patients.&#xD;
&#xD;
          4. Life expectancy less than 3 month.&#xD;
&#xD;
          5. Contraindications to pleural tissue sampling.&#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>Uffe Boedtger, MD, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Syddansk Universitet</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Naestved Hospital</name>
      <address>
        <city>Naestved</city>
        <zip>4700</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>December 2020</verification_date>
  <study_first_submitted>November 5, 2015</study_first_submitted>
  <study_first_submitted_qc>September 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 5, 2017</study_first_posted>
  <last_update_submitted>December 15, 2020</last_update_submitted>
  <last_update_submitted_qc>December 15, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">December 17, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Naestved Hospital</investigator_affiliation>
    <investigator_full_name>Simon Reuter</investigator_full_name>
    <investigator_title>Ph.d.-Student</investigator_title>
  </responsible_party>
  <keyword>Thoracoscopy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Neoplasms</mesh_term>
    <mesh_term>Pleural Effusion</mesh_term>
  </condition_browse>
  <!-- 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/NCT03272087
org study id: Resp-REPEAT-SIRE-2
nct id: NCT03272087
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
Recurrent unilateral, non-infectious pleural exudate is suspicious for primary or secondary
      pleural malignancy. Both conditions are associated with 5-year survival of 10%. Work-up is
      difficult, as the pleural surface is large and <33% of pleural malignancies shed malignant
      cells to the pleural fluid. Even so, additional tissue biopsies are needed for establishing
      mutation status for targeted therapies.

      Optimal imaging to guide tissue sampling is pivotal. PET-CT has higher sensitivity than
      conventional CT for detecting malignant lesions >10mm. However, no randomised trial has
      investigated differences in diagnostic accuracy, time-to-diagnosis, or economics. Falsely
      PET-positive lesions in e.g. colon, however, lead to more derived tests than do CT alone.

      Gold standard for pleural tissue sampling is the surgical (VATS) thoracoscopy, allowing
      direct visual guiding of tissue sampling from all pleural surfaces. Yet, globally the medical
      (pleuroscopy) thoracoscopy is more widely used: cheaper, outpatient procedure, but allows
      only sampling from the parietal pleura. To date, no randomised studies have compared medical
      and surgical thoracoscopy concerning diagnostic hit rates, adverse events, or economics.

      Investigators will perform two randomized studies to investigate whether

        1. PET/CT is comparable to CT alone

        2. VATS is comparable to pleuroscopy concerning hit rate, total investigations performed,
           time-to-diagnosis.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Number of patients diagnosed with cancer
time frame: 2 years
description: (cancer = an unequivocal diagnosis of neoplastic disease; no cancer = clinically benign cause, and improved imaging at 6 month control).
measure: Quality of life
time frame: 1 month
description: Questionnaire developed to assess the quality of life of cancer patients, QLQC 30
measure: Total costs
time frame: 2 years
description: calculated as costs patient-related, procedure-related, and overall
measure: Pain
time frame: 2 years
description: VAS scale
measure: Quality of life
time frame: 1 month
description: A standardised instrument for use as a measure of health outcome, EuroQol EQ-5D
arm group label: Pleuroscopy
arm group type: Active Comparator
description: According to BTS guideline thoracoscopy is the next procedure for patients who remain undiagnosed despite PET-CT and attempts to obtain biopsies. Eligible patients will be randomised to pleuroscopy or VATS. Patients with inconclusive pleuroscopy will proceed to VATS.
arm group label: VATS (thoracoscopy)
arm group type: Active Comparator
description: According to BTS guideline thoracoscopy is the next procedure for patients who remain undiagnosed despite PET-CT and attempts to obtain biopsies. Eligible patients will be randomised to pleuroscopy or VATS. Patients with inconclusive pleuroscopy will proceed to VATS.
intervention type: Device
intervention name: Thoracoscopy
description: 50 % of patients will have performed af medical thoracoscopy (pleuroscopy)
arm group label: Pleuroscopy
intervention type: Device
intervention name: VATS (thoracoscopy)
description: 50 % of patients will have performed a VATS (video-assisted thoracic surgery) thoracoscopy
arm group label: VATS (thoracoscopy)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Uffe Boedtger, MD, PhD
role: Study Director
affiliation: Syddansk Universitet
facility: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: Naestved Hospital
investigator full name: Simon Reuter
investigator title: Ph.d.-Student
mesh term: Lung Neoplasms
mesh term: Pleural Effusion