<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/NCT03828903</url>
  </required_header>
  <id_info>
    <org_study_id>Cryobiopsy pleural effusion</org_study_id>
    <nct_id>NCT03828903</nct_id>
  </id_info>
  <brief_title>Role of Cryobiopsy in Diagnosis of Pleural Effusion</brief_title>
  <official_title>The Diagnostic Value of Cryobiopsy During Medical Thoracoscopy in Diagnosis of Pleural Effusion</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</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>
      The purpose of this study is to evaluate the feasibility, size and quality of the specimens&#xD;
      obtained by cryoprobe in comparison to those specimens obtained by flexible forceps during&#xD;
      medical thoracoscopy in diagnosis of pleural effusion.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      -  Medical thoracoscopy with single-port-of-entry technique will be performed in the&#xD;
           bronchoscopy unit under local anesthesia and conscious sedation using midazolam (2 mg)&#xD;
           or pethidin.&#xD;
&#xD;
        -  vertical incision will be made with the scalpel (usually near the midaxillary line),&#xD;
           through the skin and subcutaneous tissue, appropriate to the size of the trocar to be&#xD;
           used, usually of approximately 10 mm, parallel with and in the middle of the selected&#xD;
           intercostal space.&#xD;
&#xD;
        -  Then the trocar will be inserted until the sudden release of resistance (after passing&#xD;
           the costal pleura) is felt.&#xD;
&#xD;
        -  Under direct vision with the thoracoscope, introduction of pneumothorax will be&#xD;
           performed, and all pleural fluid will be removed, and the pleural cavity will be&#xD;
           inspected.&#xD;
&#xD;
        -  Suspicious areas will be biopsied through the working channel of the thoracoscope.&#xD;
&#xD;
        -  two to six biopsies of a suspicious pleural lesion will establish the diagnosis.&#xD;
&#xD;
      Technique of pleural biopsy using cryotechnique:&#xD;
&#xD;
        -  The probe (ERBE Elektromedizin GmbH( Gesellschaft mit beschränkter Haftung) , Germany of&#xD;
           2.4mm) will be placed perpendicular to the surface of the parietal pleura with the tip&#xD;
           of the probe extended well beyond the tip of the scope using the marking on the probe&#xD;
           and with direct visualization.&#xD;
&#xD;
        -  The tip of the cryoprobe will be attached to suspicious part of parietal pleura and&#xD;
           activated by footswitch.&#xD;
&#xD;
        -  carbon dioxide will be used as the cryogen gas for cryobiopsy&#xD;
&#xD;
        -  The frozen tissue is going to be extracted by gently pulling of the probe.&#xD;
&#xD;
        -  Freezing will be carried out for 6 to 10 seconds depending on the visual assessment of&#xD;
           pleural texture.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 10, 2020</start_date>
  <completion_date type="Actual">October 10, 2021</completion_date>
  <primary_completion_date type="Actual">September 10, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>comparison between pleural biopsy specimens obtained by flexible forceps with those obtained with cryoprobe during medical thoracoscopy in diagnosis of pleural effusion.</measure>
    <time_frame>12 months</time_frame>
    <description>1_size of pleural biopsy obtained by cryoprobe in comparison to those obtained by flexible forceps (in millimeter).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Complication assessment</measure>
    <time_frame>12 months</time_frame>
    <description>To evaluate the safety and occurrence of complication such as bleeding Number of patients with a certain degree of bleeding from biopsy site, described as:&#xD;
1 = slight, self-limited, 2 = moderate, requiring electrocautery intervention, 3 = severe, requiring interruption of the procedure, chest tube drainage and intravenous fluid resuscitation .</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>assessment pleural fluid</measure>
    <time_frame>12 months</time_frame>
    <description>comparison between the estimate of pleural effusion using chest ultrasound and actual amount after thoracoscpic drainage, measured in mililiters.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>assessment of post procedure pain</measure>
    <time_frame>12 months</time_frame>
    <description>comparison between meperidine and (midazolam &amp;NSAIDs) in controlling pain post thoracoscopy.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Pleural Effusion</condition>
  <arm_group>
    <arm_group_label>pleural effusion patients</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>medical thoracoscopy will e performed to patients with pleural effusion and pleural biopsy by forceps ad cryoprobe will be obtained</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Cryoprobe</intervention_name>
    <description>The probe (ERBE Elektromedizin GmbH; Tubingen, Germany of 2.4mm) will be placed perpendicular to the surface of the parietal pleura with the tip of the probe extended well beyond the tip of the scope using the marking on the probe and with direct visualization.&#xD;
The tip of the cryoprobe will be attached to suspicious part of parietal pleura .&#xD;
The frozen tissue is going to be extracted by gently pulling of the probe.&#xD;
Freezing will be carried out for 6 to 10 seconds depending on the visual assessment of pleural texture.&#xD;
The probe with the attached biopsy sample is going to be removed together with the thoracoscope through trocar.&#xD;
The biopsy sample will be released from the probe by thawing in the saline.&#xD;
The semirigid pleuroscope will be reintroduced through the port and the pleura will be revisualized for bleeding.</description>
    <arm_group_label>pleural effusion patients</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - 1. Unilateral moderate or massive exudative pleural effusion patients. 2. Undiagnosed&#xD;
        pleural effusion after simple pleural fluid aspiration, cytology or blind (closed) pleural&#xD;
        biopsy using Abram's needle.&#xD;
&#xD;
        3. Age&gt;18 years old&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Transudative pleural effusion.&#xD;
&#xD;
          2. Exudative pleural effusion less than one third of hemithorax.&#xD;
&#xD;
          3. Presence of hemorrhagic diathesis (prothrombin concentration &lt;50% and platelet count&#xD;
             &lt;80,000/mm 3).&#xD;
&#xD;
          4. Poor performance state (ECOG performance status &gt;4) as recommended in BTS (British&#xD;
             thoracic society) guidelines 2010.&#xD;
&#xD;
          5. Sever uncontrollable cough, hypercapnia and sever respiratory distress.&#xD;
&#xD;
          6. Fibrothorax, excessive pleural adhesion.&#xD;
&#xD;
             -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Reham M El morshedy, Lecturer</last_name>
    <role>Principal Investigator</role>
    <affiliation>Assiut University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Assuit University hospital</name>
      <address>
        <city>Assiut</city>
        <zip>71511</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alaa Salah Abdel gany</name>
      <address>
        <city>Assiut</city>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <reference>
    <citation>Chen CH, Cheng WC, Wu BR, Chen CY, Chen WC, Liao WC, Tu CY. Feasibility and Safety of Pleuroscopic Cryobiopsy of the Pleura: A Prospective Study. Can Respir J. 2018 Jan 22;2018:6746470. doi: 10.1155/2018/6746470. eCollection 2018.</citation>
    <PMID>29610630</PMID>
  </reference>
  <reference>
    <citation>Tousheed SZ, Manjunath PH, Chandrasekar S, Murali Mohan BV, Kumar H, Hibare KR, Ramanjaneya R. Cryobiopsy of the Pleura: An Improved Diagnostic Tool. J Bronchology Interv Pulmonol. 2018 Jan;25(1):37-41. doi: 10.1097/LBR.0000000000000444.</citation>
    <PMID>29261578</PMID>
  </reference>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>January 26, 2019</study_first_submitted>
  <study_first_submitted_qc>January 31, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 4, 2019</study_first_posted>
  <last_update_submitted>November 26, 2021</last_update_submitted>
  <last_update_submitted_qc>November 26, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">December 9, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Alaa Salah Abd El Ghany</investigator_full_name>
    <investigator_title>Assistant lecturer, Chest Department and tuberculosis</investigator_title>
  </responsible_party>
  <keyword>Cryobiopsy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <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/NCT03828903
org study id: Cryobiopsy pleural effusion
nct id: NCT03828903
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to evaluate the feasibility, size and quality of the specimens
      obtained by cryoprobe in comparison to those specimens obtained by flexible forceps during
      medical thoracoscopy in diagnosis of pleural effusion.
-  Medical thoracoscopy with single-port-of-entry technique will be performed in the
           bronchoscopy unit under local anesthesia and conscious sedation using midazolam (2 mg)
           or pethidin.

        -  vertical incision will be made with the scalpel (usually near the midaxillary line),
           through the skin and subcutaneous tissue, appropriate to the size of the trocar to be
           used, usually of approximately 10 mm, parallel with and in the middle of the selected
           intercostal space.

        -  Then the trocar will be inserted until the sudden release of resistance (after passing
           the costal pleura) is felt.

        -  Under direct vision with the thoracoscope, introduction of pneumothorax will be
           performed, and all pleural fluid will be removed, and the pleural cavity will be
           inspected.

        -  Suspicious areas will be biopsied through the working channel of the thoracoscope.

        -  two to six biopsies of a suspicious pleural lesion will establish the diagnosis.

      Technique of pleural biopsy using cryotechnique:

        -  The probe (ERBE Elektromedizin GmbH( Gesellschaft mit beschränkter Haftung) , Germany of
           2.4mm) will be placed perpendicular to the surface of the parietal pleura with the tip
           of the probe extended well beyond the tip of the scope using the marking on the probe
           and with direct visualization.

        -  The tip of the cryoprobe will be attached to suspicious part of parietal pleura and
           activated by footswitch.

        -  carbon dioxide will be used as the cryogen gas for cryobiopsy

        -  The frozen tissue is going to be extracted by gently pulling of the probe.

        -  Freezing will be carried out for 6 to 10 seconds depending on the visual assessment of
           pleural texture.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: comparison between pleural biopsy specimens obtained by flexible forceps with those obtained with cryoprobe during medical thoracoscopy in diagnosis of pleural effusion.
time frame: 12 months
description: 1_size of pleural biopsy obtained by cryoprobe in comparison to those obtained by flexible forceps (in millimeter).
measure: Complication assessment
time frame: 12 months
description: To evaluate the safety and occurrence of complication such as bleeding Number of patients with a certain degree of bleeding from biopsy site, described as:
1 = slight, self-limited, 2 = moderate, requiring electrocautery intervention, 3 = severe, requiring interruption of the procedure, chest tube drainage and intravenous fluid resuscitation .
measure: assessment pleural fluid
time frame: 12 months
description: comparison between the estimate of pleural effusion using chest ultrasound and actual amount after thoracoscpic drainage, measured in mililiters.
measure: assessment of post procedure pain
time frame: 12 months
description: comparison between meperidine and (midazolam &NSAIDs) in controlling pain post thoracoscopy.
arm group label: pleural effusion patients
arm group type: Experimental
description: medical thoracoscopy will e performed to patients with pleural effusion and pleural biopsy by forceps ad cryoprobe will be obtained
intervention type: Device
intervention name: Cryoprobe
description: The probe (ERBE Elektromedizin GmbH; Tubingen, Germany of 2.4mm) will be placed perpendicular to the surface of the parietal pleura with the tip of the probe extended well beyond the tip of the scope using the marking on the probe and with direct visualization.
The tip of the cryoprobe will be attached to suspicious part of parietal pleura .
The frozen tissue is going to be extracted by gently pulling of the probe.
Freezing will be carried out for 6 to 10 seconds depending on the visual assessment of pleural texture.
The probe with the attached biopsy sample is going to be removed together with the thoracoscope through trocar.
The biopsy sample will be released from the probe by thawing in the saline.
The semirigid pleuroscope will be reintroduced through the port and the pleura will be revisualized for bleeding.
arm group label: pleural effusion patients
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Reham M El morshedy, Lecturer
role: Principal Investigator
affiliation: Assiut University
facility: 
facility: 
country: Egypt
citation: Chen CH, Cheng WC, Wu BR, Chen CY, Chen WC, Liao WC, Tu CY. Feasibility and Safety of Pleuroscopic Cryobiopsy of the Pleura: A Prospective Study. Can Respir J. 2018 Jan 22;2018:6746470. doi: 10.1155/2018/6746470. eCollection 2018.
PMID: 29610630
citation: Tousheed SZ, Manjunath PH, Chandrasekar S, Murali Mohan BV, Kumar H, Hibare KR, Ramanjaneya R. Cryobiopsy of the Pleura: An Improved Diagnostic Tool. J Bronchology Interv Pulmonol. 2018 Jan;25(1):37-41. doi: 10.1097/LBR.0000000000000444.
PMID: 29261578
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Alaa Salah Abd El Ghany
investigator title: Assistant lecturer, Chest Department and tuberculosis
mesh term: Pleural Effusion