<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/NCT01726556</url>
  </required_header>
  <id_info>
    <org_study_id>1Trg-PG-2012/5054</org_study_id>
    <nct_id>NCT01726556</nct_id>
  </id_info>
  <brief_title>A Trial of Rigid Versus Semirigid Thoracoscopy in the Evaluation of Exudative Pleural Effusions</brief_title>
  <acronym>RISE</acronym>
  <official_title>A Randomized Controlled Trial of Rigid Versus Semirigid Thoracoscopy in the Evaluation of Exudative Pleural Effusions</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Postgraduate Institute of Medical Education and Research</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Postgraduate Institute of Medical Education and Research</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Rigid thoracoscopy is an established procedure for the performance of pleural biopsies for&#xD;
      undiagnosed pleural effusions. The semirigid thoracoscope is a relatively new instrument&#xD;
      designed for the same purpose which is claimed to be more user-friendly. The two devices have&#xD;
      not been compared in a head-to-head trial in published literature. The investigators attempt&#xD;
      to conduct a randomised comparative trial between the two devices.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>April 2011</start_date>
  <completion_date type="Actual">December 2012</completion_date>
  <primary_completion_date type="Actual">December 2012</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>Crossover Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Diagnostic yield of thoracoscopic biopsy by intention to treat analysis</measure>
    <time_frame>3 months</time_frame>
    <description>The proportion of patients where thoracoscopic pleural biopsy yielded a diagnosis that was consistent with the present clinical picture and the further follow-up of the patients, would be calculated and compared between the two arms</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Yield of biopsies successfully completed</measure>
    <time_frame>3 months</time_frame>
    <description>The diagnostic yield of only those procedures would be considered separately where a biopsy could be successfully done and compared between the two arms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complications</measure>
    <time_frame>3 months</time_frame>
    <description>Number of major and minor complications encountered in the two arms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Scar size</measure>
    <time_frame>At the end of the procedure</time_frame>
    <description>Scar size (in mm) in the longest axis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Biopsy size</measure>
    <time_frame>At the end of the procedure</time_frame>
    <description>Biopsy size (in mm) in the longest axis</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Use of sedation and analgesia during the procedure</measure>
    <time_frame>At the end of procedure</time_frame>
    <description>The quantity of drugs used for sedation and analgesia during the procedure would be recorded and compared between the two arms</description>
  </other_outcome>
  <other_outcome>
    <measure>Operators' experience characteristics</measure>
    <time_frame>At the end of the procedure</time_frame>
    <description>These would include, on a numerical scale of 0 to 100, the operator's grading of the following characteristics: quality of thoracoscopic image, ease of maneuvering, ease of taking a biopsy and the operator's expectation that the biopsy will reveal a definitive histological diagnosis</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">70</enrollment>
  <condition>Pleurisy With Effusion</condition>
  <arm_group>
    <arm_group_label>Rigid thoracoscopy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Rigid thoracoscopy would be done using a rigid thoracoscope manufactured by Richard Wolf GmbH, Knittlingen, Germany.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Semirigid thoracoscopy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The semirigid thoracoscope employed is a model LTF-160Y1, manufactured by Olympus Medical Systems Corporation, Tokyo, Japan.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Rigid thoracoscope (Richard Wolf GmbH, Knittlingen, Germany)</intervention_name>
    <description>Pleuroscopy using a rigid thoracoscope manufactured by Richard Wolf GmbH, Knittlingen, Germany</description>
    <arm_group_label>Rigid thoracoscopy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Semirigid thoracoscope (model LTF-160Y1, Olympus, Japan)</intervention_name>
    <description>Pleuroscopy using a semirigid thoracoscope model LTF-160Y1, manufactured by Olympus Medical Systems Corporation, Tokyo, Japan</description>
    <arm_group_label>Semirigid thoracoscopy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with an exudative (as defined by Light's criteria) pleural effusion of&#xD;
             unknown etiology after a microbiological (namely gram stain and acid fast bacillus&#xD;
             stain) and cytological examination&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Significant hypoxemia on room air&#xD;
&#xD;
          -  Hemodynamic instability&#xD;
&#xD;
          -  Significant cardiac disease (known myocardial infarction in last 6 weeks or presence&#xD;
             of unstable angina)&#xD;
&#xD;
          -  Refractory cough&#xD;
&#xD;
          -  Lack of pleural space due to adhesions&#xD;
&#xD;
          -  Uncorrected coagulopathy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ritesh Agarwal, MD, DM</last_name>
    <role>Principal Investigator</role>
    <affiliation>PGIMER, Chandigarh</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Postgraduate Institute of Medical Education and Research</name>
      <address>
        <city>Chandigarh</city>
        <zip>160012</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>India</country>
  </location_countries>
  <verification_date>January 2013</verification_date>
  <study_first_submitted>November 7, 2012</study_first_submitted>
  <study_first_submitted_qc>November 10, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 15, 2012</study_first_posted>
  <last_update_submitted>January 9, 2013</last_update_submitted>
  <last_update_submitted_qc>January 9, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 10, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Postgraduate Institute of Medical Education and Research</investigator_affiliation>
    <investigator_full_name>Sahajal Dhooria</investigator_full_name>
    <investigator_title>Senior Resident</investigator_title>
  </responsible_party>
  <keyword>Pleural effusion</keyword>
  <keyword>Semirigid thoracoscopy</keyword>
  <keyword>Rigid thoracoscopy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pleurisy</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/NCT01726556
org study id: 1Trg-PG-2012/5054
nct id: NCT01726556
lead sponsor: 
has dmc: No
Rigid thoracoscopy is an established procedure for the performance of pleural biopsies for
      undiagnosed pleural effusions. The semirigid thoracoscope is a relatively new instrument
      designed for the same purpose which is claimed to be more user-friendly. The two devices have
      not been compared in a head-to-head trial in published literature. The investigators attempt
      to conduct a randomised comparative trial between the two devices.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Diagnostic yield of thoracoscopic biopsy by intention to treat analysis
time frame: 3 months
description: The proportion of patients where thoracoscopic pleural biopsy yielded a diagnosis that was consistent with the present clinical picture and the further follow-up of the patients, would be calculated and compared between the two arms
measure: Yield of biopsies successfully completed
time frame: 3 months
description: The diagnostic yield of only those procedures would be considered separately where a biopsy could be successfully done and compared between the two arms
measure: Complications
time frame: 3 months
description: Number of major and minor complications encountered in the two arms
measure: Scar size
time frame: At the end of the procedure
description: Scar size (in mm) in the longest axis
measure: Biopsy size
time frame: At the end of the procedure
description: Biopsy size (in mm) in the longest axis
measure: Use of sedation and analgesia during the procedure
time frame: At the end of procedure
description: The quantity of drugs used for sedation and analgesia during the procedure would be recorded and compared between the two arms
measure: Operators' experience characteristics
time frame: At the end of the procedure
description: These would include, on a numerical scale of 0 to 100, the operator's grading of the following characteristics: quality of thoracoscopic image, ease of maneuvering, ease of taking a biopsy and the operator's expectation that the biopsy will reveal a definitive histological diagnosis
arm group label: Rigid thoracoscopy
arm group type: Active Comparator
description: Rigid thoracoscopy would be done using a rigid thoracoscope manufactured by Richard Wolf GmbH, Knittlingen, Germany.
arm group label: Semirigid thoracoscopy
arm group type: Active Comparator
description: The semirigid thoracoscope employed is a model LTF-160Y1, manufactured by Olympus Medical Systems Corporation, Tokyo, Japan.
intervention type: Device
intervention name: Rigid thoracoscope (Richard Wolf GmbH, Knittlingen, Germany)
description: Pleuroscopy using a rigid thoracoscope manufactured by Richard Wolf GmbH, Knittlingen, Germany
arm group label: Rigid thoracoscopy
intervention type: Device
intervention name: Semirigid thoracoscope (model LTF-160Y1, Olympus, Japan)
description: Pleuroscopy using a semirigid thoracoscope model LTF-160Y1, manufactured by Olympus Medical Systems Corporation, Tokyo, Japan
arm group label: Semirigid thoracoscopy
criteria: 
gender: All
minimum age: 12 Years
maximum age: N/A
healthy volunteers: No
last name: Ritesh Agarwal, MD, DM
role: Principal Investigator
affiliation: PGIMER, Chandigarh
facility: 
country: India
responsible party type: Principal Investigator
investigator affiliation: Postgraduate Institute of Medical Education and Research
investigator full name: Sahajal Dhooria
investigator title: Senior Resident
mesh term: Pleurisy
mesh term: Pleural Effusion