<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/NCT03804957</url>
  </required_header>
  <id_info>
    <org_study_id>ICH-BloodyBiopsy</org_study_id>
    <nct_id>NCT03804957</nct_id>
  </id_info>
  <brief_title>Pneumothorax After CT-guided Lung Biopsy: Standard vs Autologous Blood Patching</brief_title>
  <acronym>BloodyBiopsy</acronym>
  <official_title>The Incidence of Pneumothorax After CT-guided Lung Biopsy Performed With and Without Autologous Blood Patching: a Randomized Single-center Prospective Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Humanitas Clinical and Research Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Humanitas Clinical and Research Center</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 aim of this prospective, randomized study is to compare the rate of postoperative&#xD;
      pneumothorax between standard CT-guided core needle biopsy (CNB) versus CNB followed by&#xD;
      autologous blood patch injection (ABPI).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Pneumothorax is the most common complication of percutaneous lung biopsies. Reducing this&#xD;
      risk is a goal of those who perform these procedures, particularly a reduction in large&#xD;
      pneumothoraces requiring intervention (eg, pleural drainage) and hospitalization (Clayton et&#xD;
      al. 2016). Recently, autologous blood patch injection (ABPI) inside the biopsy track has been&#xD;
      suggested as an effective mean of sealing the punctured lung thus halting air loss and&#xD;
      consequently pneumothorax (Graffy et al. 2017).&#xD;
&#xD;
      The aim of this prospective, randomized study is to compare the rate of postoperative&#xD;
      pneumothorax between standard CT-guided core needle biopsy (CNB) versus CNB followed by ABPI.&#xD;
&#xD;
      In particular, the main objectives are to compare:&#xD;
&#xD;
        1. incidence of immediate pneumothorax&#xD;
&#xD;
        2. incidence of late pneumothorax (2 hrs)&#xD;
&#xD;
        3. incidence of chest tube placement&#xD;
&#xD;
        4. duration of the procedure&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">January 2019</start_date>
  <completion_date type="Anticipated">April 2020</completion_date>
  <primary_completion_date type="Anticipated">December 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>
    <intervention_model_description>Randomized two arms single center</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Early Pneumothorax after biopsy</measure>
    <time_frame>Immediately after lung puncture</time_frame>
    <description>Early Pneumothorax after biopsy as seen by immediate post-biopsy CT and X-ray</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Late Pneumothorax after biopsy</measure>
    <time_frame>2-6 hours</time_frame>
    <description>Delayed Pneumothorax after biopsy as seen by X-ray after 2-6 hours</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Pneumothorax</condition>
  <condition>Biopsy Wound</condition>
  <arm_group>
    <arm_group_label>CT-guided core needle biopsy (CNB)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>18 gauge ct-guided lung biopsy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CNB followed by ABPI.</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>17 gauge coaxial needle for a 18g ct-guided lung biopsy followed by autologous blood patch injection</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Autologous blood patch injection (ABPI)</intervention_name>
    <description>Autologous blood patch injection (ABPI) through a coaxial needle at the site of biopsy</description>
    <arm_group_label>CNB followed by ABPI.</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>CT-guided core needle biopsy (CNB)</intervention_name>
    <description>Standard 18g lung core biopsy</description>
    <arm_group_label>CT-guided core needle biopsy (CNB)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        All patients scheduled for lung biopsy will be asked to join this study. After signing the&#xD;
        informed consent the subject will be randomized for ABPI vs CNB approach.&#xD;
&#xD;
        Inclusion criteria:&#xD;
&#xD;
        1) patients with pulmonary nodule requiring CT-guided lung biopsy.&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          1. unfit for lung biopsy (INR &gt;1.5, PLT &lt;50.000, single lung);&#xD;
&#xD;
          2. unavailable venous access.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>EZIO LANZA, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Humanitas Research Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>EZIO LANZA, MD</last_name>
    <phone>0282247383</phone>
    <email>eziolanza@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>FRANCESCA PICCOLI, MD</last_name>
    <email>francesca.piccoli3@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Humanitas Research Hospital</name>
      <address>
        <city>Rozzano</city>
        <state>Lombardia</state>
        <zip>20089</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <results_reference>
    <citation>Maybody M, Muallem N, Brown KT, Moskowitz CS, Hsu M, Zenobi CL, Jihad M, Getrajdman GI, Sofocleous CT, Erinjeri JP, Covey AM, Brody LA, Yarmohammadi H, Deipolyi AR, Bryce Y, Alago W, Siegelbaum RH, Durack JC, Gonzalez-Aguirre AJ, Ziv E, Boas FE, Solomon SB. Autologous Blood Patch Injection versus Hydrogel Plug in CT-guided Lung Biopsy: A Prospective Randomized Trial. Radiology. 2019 Feb;290(2):547-554. doi: 10.1148/radiol.2018181140. Epub 2018 Nov 27.</citation>
    <PMID>30480487</PMID>
  </results_reference>
  <results_reference>
    <citation>Graffy P, Loomis SB, Pickhardt PJ, Lubner MG, Kitchin DR, Lee FT Jr, Hinshaw JL. Pulmonary Intraparenchymal Blood Patching Decreases the Rate of Pneumothorax-Related Complications following Percutaneous CT-Guided Needle Biopsy. J Vasc Interv Radiol. 2017 Apr;28(4):608-613.e1. doi: 10.1016/j.jvir.2016.12.1217. Epub 2017 Feb 6.</citation>
    <PMID>28185770</PMID>
  </results_reference>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>December 24, 2018</study_first_submitted>
  <study_first_submitted_qc>January 11, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 15, 2019</study_first_posted>
  <last_update_submitted>January 11, 2019</last_update_submitted>
  <last_update_submitted_qc>January 11, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 15, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>biopsy</keyword>
  <keyword>pneumothorax</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pneumothorax</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03804957
org study id: ICH-BloodyBiopsy
nct id: NCT03804957
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this prospective, randomized study is to compare the rate of postoperative
      pneumothorax between standard CT-guided core needle biopsy (CNB) versus CNB followed by
      autologous blood patch injection (ABPI).
Pneumothorax is the most common complication of percutaneous lung biopsies. Reducing this
      risk is a goal of those who perform these procedures, particularly a reduction in large
      pneumothoraces requiring intervention (eg, pleural drainage) and hospitalization (Clayton et
      al. 2016). Recently, autologous blood patch injection (ABPI) inside the biopsy track has been
      suggested as an effective mean of sealing the punctured lung thus halting air loss and
      consequently pneumothorax (Graffy et al. 2017).

      The aim of this prospective, randomized study is to compare the rate of postoperative
      pneumothorax between standard CT-guided core needle biopsy (CNB) versus CNB followed by ABPI.

      In particular, the main objectives are to compare:

        1. incidence of immediate pneumothorax

        2. incidence of late pneumothorax (2 hrs)

        3. incidence of chest tube placement

        4. duration of the procedure
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomized two arms single center
primary purpose: Prevention
masking: None (Open Label)
measure: Early Pneumothorax after biopsy
time frame: Immediately after lung puncture
description: Early Pneumothorax after biopsy as seen by immediate post-biopsy CT and X-ray
measure: Late Pneumothorax after biopsy
time frame: 2-6 hours
description: Delayed Pneumothorax after biopsy as seen by X-ray after 2-6 hours
arm group label: CT-guided core needle biopsy (CNB)
arm group type: Active Comparator
description: 18 gauge ct-guided lung biopsy
arm group label: CNB followed by ABPI.
arm group type: Experimental
description: 17 gauge coaxial needle for a 18g ct-guided lung biopsy followed by autologous blood patch injection
intervention type: Other
intervention name: Autologous blood patch injection (ABPI)
description: Autologous blood patch injection (ABPI) through a coaxial needle at the site of biopsy
arm group label: CNB followed by ABPI.
intervention type: Other
intervention name: CT-guided core needle biopsy (CNB)
description: Standard 18g lung core biopsy
arm group label: CT-guided core needle biopsy (CNB)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: EZIO LANZA, MD
role: Principal Investigator
affiliation: Humanitas Research Hospital
last name: EZIO LANZA, MD
phone: 0282247383
email: eziolanza@gmail.com
last name: FRANCESCA PICCOLI, MD
email: francesca.piccoli3@gmail.com
facility: 
country: Italy
citation: Maybody M, Muallem N, Brown KT, Moskowitz CS, Hsu M, Zenobi CL, Jihad M, Getrajdman GI, Sofocleous CT, Erinjeri JP, Covey AM, Brody LA, Yarmohammadi H, Deipolyi AR, Bryce Y, Alago W, Siegelbaum RH, Durack JC, Gonzalez-Aguirre AJ, Ziv E, Boas FE, Solomon SB. Autologous Blood Patch Injection versus Hydrogel Plug in CT-guided Lung Biopsy: A Prospective Randomized Trial. Radiology. 2019 Feb;290(2):547-554. doi: 10.1148/radiol.2018181140. Epub 2018 Nov 27.
PMID: 30480487
citation: Graffy P, Loomis SB, Pickhardt PJ, Lubner MG, Kitchin DR, Lee FT Jr, Hinshaw JL. Pulmonary Intraparenchymal Blood Patching Decreases the Rate of Pneumothorax-Related Complications following Percutaneous CT-Guided Needle Biopsy. J Vasc Interv Radiol. 2017 Apr;28(4):608-613.e1. doi: 10.1016/j.jvir.2016.12.1217. Epub 2017 Feb 6.
PMID: 28185770
responsible party type: Sponsor
mesh term: Pneumothorax
sharing ipd: Undecided