<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/NCT04415255</url>
  </required_header>
  <id_info>
    <org_study_id>18-AKD-150</org_study_id>
    <secondary_id>13.07.2018 1.0</secondary_id>
    <nct_id>NCT04415255</nct_id>
  </id_info>
  <brief_title>Novel Use of Extrapleural Autologous Blood Injection in CT-guided Percutaneous Lung Biopsy</brief_title>
  <official_title>Novel Use of Extrapleural Autologous Blood Injection in CT-guided Percutaneous Lung Biopsy and Its Comparison to Intraparenchymal Autologous Blood Patch Injection: A Single-center, Prospective, Randomized, and Controlled Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Namik Kemal University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Namik Kemal 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 rate of iatrogenic pneumothorax and the need for&#xD;
      intervention with extrapleural autologous blood injection (EPABI) along with intraparenchymal&#xD;
      autologous blood patch injection (IABPI) or IABPI-alone in CT-guided percutaneous lung&#xD;
      biopsy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The mechanism of pneumothorax is postulated to be due to the air leakage through the puncture&#xD;
      hole when the needle is removed after the biopsy. However, pneumothorax may occur during the&#xD;
      needle insertion as the visceral pleura is punctured or during the biopsy procedure before&#xD;
      needle removal. Prevent such leakage, the investigators planned to inject autologous blood&#xD;
      into the extrapleural space to prevent pneumothorax during needle entry. The extrapleural&#xD;
      autologous blood injection (EPABI) is expected to form a space-occupying hematoma pressing on&#xD;
      visceral pleura as a sealant. The investigators planned to test the EPABI method in a&#xD;
      prospective single-center randomized controlled study design.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 1, 2018</start_date>
  <completion_date type="Actual">October 31, 2019</completion_date>
  <primary_completion_date type="Actual">April 30, 2019</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>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>To evaluate the rate of iatrogenic pneumothorax and the need for intervention with extrapleural autologous blood injection (EPABI)</measure>
    <time_frame>1 years</time_frame>
    <description>the rate of pneumothorax</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">139</enrollment>
  <condition>Lung Biopsy</condition>
  <arm_group>
    <arm_group_label>EPABI &amp; IABPI</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>extrapleural autologous blood injection (EPABI) along with intraparenchymal autologous blood patch injection (IABPI)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>IABPI-alone</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>intraparenchymal autologous blood patch injection (IABPI)</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>EABPI plus IABPI</intervention_name>
    <description>If the patient was assigned to EPABI plus IABPI, while the extrapleural space was reached, ~ 15 ml of autologous blood was injected at the extrapleural space through the coaxial needle. Then the central stylet was reinserted and the coaxial needle was advanced into the lung parenchyma with a single puncture. The needle was stopped inside the proximal part of the target and the center needle was removed. A 20-G/16 cm fully-automated biopsy needle was introduced through the 19-G/13.8 cm coaxial needle and specimens were identically obtained. After specimens were collected, the biopsy needle was removed, and immediately the remaining autologous blood (~5 ml) was slowly injected through the coaxial needle as it was withdrawn through the parenchyma thus sealing the needle tract.</description>
    <arm_group_label>EPABI &amp; IABPI</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>IABPI-alone</intervention_name>
    <description>If the patient was assigned to IABPI-alone, after collecting the biopsy specimens, immediately the autologous blood (~5 ml) was slowly injected through the coaxial needle as it was withdrawn through the parenchyma thus sealing the needle tract.</description>
    <arm_group_label>IABPI-alone</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ≥18 years of age&#xD;
&#xD;
          -  Referred for CT guided biopsy of lung lesion&#xD;
&#xD;
          -  Target lesion of any size&#xD;
&#xD;
          -  Target lesion located any away from visceral pleura based on the needle path&#xD;
&#xD;
          -  Needle path without transgression of a pleural fissure, bleb, or bulla is possible&#xD;
&#xD;
          -  Coaxial biopsy technique using Bard 19-Gauge introducer needle&#xD;
&#xD;
          -  Needle length =16&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Passage through non-aerated lung or tissue&#xD;
&#xD;
          -  More than 1 biopsy on the same side requiring more than 1 pleural puncture&#xD;
&#xD;
          -  History of prior ipsilateral lung interventions including:&#xD;
&#xD;
        Chest tube placement Surgery Pleurodesis Radiation treatment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yasar Turk</last_name>
    <role>Principal Investigator</role>
    <affiliation>Namik Kemal University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Tekirdag Namik Kemal University Medical Faculty Radiology Department</name>
      <address>
        <city>Tekirdag</city>
        <zip>59100</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>May 29, 2020</study_first_submitted>
  <study_first_submitted_qc>June 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>June 5, 2020</last_update_submitted>
  <last_update_submitted_qc>June 5, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 9, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Namik Kemal University</investigator_affiliation>
    <investigator_full_name>Yasar Turk</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04415255
org study id: 18-AKD-150
secondary id: 13.07.2018 1.0
nct id: NCT04415255
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to evaluate the rate of iatrogenic pneumothorax and the need for
      intervention with extrapleural autologous blood injection (EPABI) along with intraparenchymal
      autologous blood patch injection (IABPI) or IABPI-alone in CT-guided percutaneous lung
      biopsy.
The mechanism of pneumothorax is postulated to be due to the air leakage through the puncture
      hole when the needle is removed after the biopsy. However, pneumothorax may occur during the
      needle insertion as the visceral pleura is punctured or during the biopsy procedure before
      needle removal. Prevent such leakage, the investigators planned to inject autologous blood
      into the extrapleural space to prevent pneumothorax during needle entry. The extrapleural
      autologous blood injection (EPABI) is expected to form a space-occupying hematoma pressing on
      visceral pleura as a sealant. The investigators planned to test the EPABI method in a
      prospective single-center randomized controlled study design.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: To evaluate the rate of iatrogenic pneumothorax and the need for intervention with extrapleural autologous blood injection (EPABI)
time frame: 1 years
description: the rate of pneumothorax
arm group label: EPABI & IABPI
arm group type: Experimental
description: extrapleural autologous blood injection (EPABI) along with intraparenchymal autologous blood patch injection (IABPI)
arm group label: IABPI-alone
arm group type: Active Comparator
description: intraparenchymal autologous blood patch injection (IABPI)
intervention type: Other
intervention name: EABPI plus IABPI
description: If the patient was assigned to EPABI plus IABPI, while the extrapleural space was reached, ~ 15 ml of autologous blood was injected at the extrapleural space through the coaxial needle. Then the central stylet was reinserted and the coaxial needle was advanced into the lung parenchyma with a single puncture. The needle was stopped inside the proximal part of the target and the center needle was removed. A 20-G/16 cm fully-automated biopsy needle was introduced through the 19-G/13.8 cm coaxial needle and specimens were identically obtained. After specimens were collected, the biopsy needle was removed, and immediately the remaining autologous blood (~5 ml) was slowly injected through the coaxial needle as it was withdrawn through the parenchyma thus sealing the needle tract.
arm group label: EPABI & IABPI
intervention type: Other
intervention name: IABPI-alone
description: If the patient was assigned to IABPI-alone, after collecting the biopsy specimens, immediately the autologous blood (~5 ml) was slowly injected through the coaxial needle as it was withdrawn through the parenchyma thus sealing the needle tract.
arm group label: IABPI-alone
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Yasar Turk
role: Principal Investigator
affiliation: Namik Kemal University
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Namik Kemal University
investigator full name: Yasar Turk
investigator title: Assistant Professor
sharing ipd: No