<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/NCT03004586</url>
  </required_header>
  <id_info>
    <org_study_id>2016-0561</org_study_id>
    <secondary_id>NCI-2017-00624</secondary_id>
    <nct_id>NCT03004586</nct_id>
  </id_info>
  <brief_title>Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration Using a 22 vs 25-Gauge Needle</brief_title>
  <official_title>Endobronchial Ultrasound-guided Transbronchial Needle Aspiration Using a 22 vs 25-Gauge Needle; A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>M.D. Anderson Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Boston Scientific Corporation</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>M.D. Anderson Cancer Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The goal of this clinical research study is to compare the effectiveness of a smaller,&#xD;
      25-gauge needle when used in an endobronchial ultrasound-guided transbronchial needle&#xD;
      aspiration (EBUS-TBNA) instead of a standard 22-gauge needle.&#xD;
&#xD;
      The safety of the needles will also be studied.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      As a part of participant's standard-of-care, participant will have a bronchoscopy of lesions&#xD;
      on participant's lung nodules and/or lymph nodes before the EBUS-TBNA. Participant will sign&#xD;
      a separate consent for the bronchoscopy.&#xD;
&#xD;
      If participant agrees to take part in this study, before participant's bronchoscopy,&#xD;
      participant will be randomly assigned (as in the flip of a coin) to 1 of 2 study groups. This&#xD;
      is done because no one knows if one study group is better, the same, or worse than the other&#xD;
      group.&#xD;
&#xD;
        -  If participant is in Group 1, participant will have the EBUS-TBNA performed by first&#xD;
           using a 25-gauge needle, followed by a 22-gauge needle.&#xD;
&#xD;
        -  If participant is in Group 2, participant will have the EBUS-TBNA performed by first&#xD;
           using a 22-gauge needle, followed by a 25-gauge needle.&#xD;
&#xD;
      To perform an EBUS-TBNA, a needle is inserted into the affected area using ultrasound imaging&#xD;
      to collect tissue from the lungs and lymph nodes. The doctor will use the imaging to guide&#xD;
      the needle into the area.&#xD;
&#xD;
      Length of Study:&#xD;
&#xD;
      Participation on the study will be over after the bronchoscopy and EBUS-TBNA.&#xD;
&#xD;
      This is an investigational study. The 22-gauge and 25-gauge needles are FDA approved for use&#xD;
      in EBUS-TBNAs. The comparison of the 2 needles for this procedure is investigational. The&#xD;
      study doctor can explain how the needles are designed to work.&#xD;
&#xD;
      Up to 120 participants will be enrolled in this study. All will take part at MD Anderson.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 16, 2016</start_date>
  <completion_date type="Actual">June 25, 2020</completion_date>
  <primary_completion_date type="Actual">June 25, 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>Crossover Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Lymph Nodes With Adequate Samples</measure>
    <time_frame>One to two hours.</time_frame>
    <description>The primary outcome was the proportion of concordance between the 22-gauge and 25-gauge needles in sample adequacy after two passes. The intervention group each of the lymph nodes sampled first with 25 gauge-needle, then the 22 gauge-needle. The Control Group each of the 200 lymph nodes were sampled first with the 22 gauge- needles, then the 25 gauge-needle. Sample adequacy was assessed after 2 passes using each needle in all participants and recorded.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Concordance With the Final Diagnosis</measure>
    <time_frame>One to two hours</time_frame>
    <description>The difference in the diagnostic yield between the 22-gauge and 25-gauge needles in terms of degree of concordance with the final diagnosis. The intervention group each of the lymph nodes sampled first with 25 gauge-needle, then the 22 gauge-needle. The Control Group each of the 200 lymph nodes were sampled first with the 22 gauge- needles, then the 25 gauge-needle. The percentage of concordance was calculated by comparing the 2 passes from each needle to the final diagnosis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Usability of the Needle</measure>
    <time_frame>1-2 hours (Intra procedurally)</time_frame>
    <description>The difference in usability between the 22-gauge and 25-gauge needles. All participant's lymph nodes were sampled by two 25-gauge needles and two 22-gauge needles for a total of 4 needles per person. Measured by a Likert scale 1-5 with 1 being the lowest and 5 being the maximum score. The intervention group each of the lymph nodes sampled first with 25 gauge-needle, then the 22 gauge-needle. The Control Group each of the 200 lymph nodes were sampled first with the 22 gauge- needles, then the 25 gauge-needle. The participants are reported per intervention.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">61</enrollment>
  <condition>Malignant Neoplasm of Respiratory and Intrathoracic Organ Carcinoma</condition>
  <condition>Lung Cancer</condition>
  <arm_group>
    <arm_group_label>EBUS-TBNA:First Using a 25-Gauge Needle Then 22-gauge Needle</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) performed by first using a 25-gauge needle, followed by a 22-gauge needle.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>EBUS-TBNA:First Using a 22-Gauge Needle Then 25-gauge Needle</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) performed by first using a 22-gauge needle, followed by a 25-gauge needle.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>25-Gauge Needle</intervention_name>
    <description>Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) performed by using a 25-gauge needle.</description>
    <arm_group_label>EBUS-TBNA:First Using a 22-Gauge Needle Then 25-gauge Needle</arm_group_label>
    <arm_group_label>EBUS-TBNA:First Using a 25-Gauge Needle Then 22-gauge Needle</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>22-Gauge Needle</intervention_name>
    <description>Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) performed by using a 25-gauge needle.</description>
    <arm_group_label>EBUS-TBNA:First Using a 22-Gauge Needle Then 25-gauge Needle</arm_group_label>
    <arm_group_label>EBUS-TBNA:First Using a 25-Gauge Needle Then 22-gauge Needle</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration (EBUS-TBNA)</intervention_name>
    <description>Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) performed.</description>
    <arm_group_label>EBUS-TBNA:First Using a 22-Gauge Needle Then 25-gauge Needle</arm_group_label>
    <arm_group_label>EBUS-TBNA:First Using a 25-Gauge Needle Then 22-gauge Needle</arm_group_label>
    <other_name>EBUS-TBNA</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age 18 years or older&#xD;
&#xD;
          2. Indication for EBUS-guided needle biopsy based on suspicion of either benign or&#xD;
             malignant disease in mediastinal or hilar lymph nodes.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients who are pregnant or lactating&#xD;
&#xD;
          2. Inability to give informed consent&#xD;
&#xD;
          3. Patients in which only one lymph node station is expected to be sampled by the&#xD;
             performing clinician.&#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>George A. Eapen, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>M.D. Anderson Cancer Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Texas MD Anderson Cancer Center</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.mdanderson.org</url>
    <description>University of Texas MD Anderson Cancer Center Website</description>
  </link>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>December 19, 2016</study_first_submitted>
  <study_first_submitted_qc>December 22, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 29, 2016</study_first_posted>
  <results_first_submitted>June 22, 2021</results_first_submitted>
  <results_first_submitted_qc>May 25, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">June 22, 2022</results_first_posted>
  <last_update_submitted>May 25, 2022</last_update_submitted>
  <last_update_submitted_qc>May 25, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">June 22, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Malignant Neoplasm of Respiratory and Intrathoracic Organ Carcinoma</keyword>
  <keyword>Lung cancer</keyword>
  <keyword>Ultrasound-guided transbronchial needle aspiration</keyword>
  <keyword>EBUS-TBNA</keyword>
  <keyword>25-gauge needle</keyword>
  <keyword>22-gauge needle</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasms</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>September 20, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/86/NCT03004586/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>A total of 61 patients were enrolled with a total of 200 lymph node stations evaluated. We randomized the &quot;needle size order&quot; on a per-patient basis with first three needle passes performed with one needle and the remaining 4th and 5th needle passes performed with the other needle. All participants completed the studies and there were no dropouts. Since the randomization was done at the lymph node level, both arms had equal number of participants.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Intervention Group: First Using a 25-gauge Needle Then 22-gauge Needle</title>
          <description>Participants in this group had their lymph nodes sampled with 25-gauge needle first followed by the 22-gauge needle.</description>
        </group>
        <group group_id="P2">
          <title>Control Group: First Using a 22-gauge Needle Then 25-gauge Needle</title>
          <description>Participants in this group had their lymph nodes sampled with 22-gauge needle first followed by the 25-gauge needle.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="31"/>
                <participants group_id="P2" count="30"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="31"/>
                <participants group_id="P2" count="30"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>All Study Participants</title>
          <description>Participants had their lymph nodes sampled both with 25-gauge needle first followed by the 22-gauge needle and 22-gauge needle first followed by the 25-gauge needle.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="61"/>
          </count_list>
        </analyzed>
        <analyzed>
          <units>Lymph nodes</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="200"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <units_analyzed>Participants</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="B1" value="61"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Lymph nodes</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="B1" value="200"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="66.8" spread="10.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <units_analyzed>Participants</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="B1" value="61"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Lymph nodes</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="B1" value="200"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="27"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <units_analyzed>Participants</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="B1" value="0"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Lymph nodes</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="B1" value="200"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <units_analyzed>Participants</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="B1" value="61"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Lymph nodes</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="B1" value="200"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Lymph Nodes Station</title>
          <units>lymph nodes</units>
          <param>Number</param>
          <units_analyzed>Participants</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="B1" value="61"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Lymph nodes</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="B1" value="200"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Lymph Node Station: 11Rs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lymph Node Station: 11Ri</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lymph Node Station: 10R</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lymph Node Station: 4R</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lymph Node Station: 2R</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lymph Node Station: 7</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lymph Node Station: 4L</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lymph Node Station: 10L</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lymph Node Station: 11L</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lymph Node Station: 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lymph Node Station: Mass (central)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>CT Scan Nodal Diameter Short Axis (mm)</title>
          <units>millimeters</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <units_analyzed>Participants</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="B1" value="61"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Lymph nodes</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="B1" value="200"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9.1" spread="5.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>EBUS Nodal Diameter Short Axis (mm)</title>
          <units>millimeters</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <units_analyzed>Participants</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="B1" value="61"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Lymph nodes</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="B1" value="200"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9.5" spread="4.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Lymph Node Characteristic</title>
          <units>lymph nodes</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <units_analyzed>Participants</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="B1" value="61"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Lymph nodes</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="B1" value="200"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Lymph Node Characteristic: Normal</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="94" spread="47.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lymph Node Characteristic: Tumor (Cohesive)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="24" spread="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lymph Node Characteristic: Tumor (Dis-cohesive)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="11" spread="5.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lymph Node Characteristic: Granulomas/Sclerotic</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6" spread="3.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lymph Node Characteristic: Non-diagnostic</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10" spread="5.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Final Diagnosis</title>
          <units>lymph nodes</units>
          <param>Number</param>
          <units_analyzed>Participants</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="B1" value="61"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Lymph nodes</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="B1" value="200"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Final Diagnosis: Inadequate/Non-diagnostic</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Final Diagnosis: Normal Lymphoid Tissue</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="128"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Final Diagnosis: Granulomatous Inflammation</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Final Diagnosis: Necrosis</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Final Diagnosis: Malignancy</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Lymph Nodes With Adequate Samples</title>
        <description>The primary outcome was the proportion of concordance between the 22-gauge and 25-gauge needles in sample adequacy after two passes. The intervention group each of the lymph nodes sampled first with 25 gauge-needle, then the 22 gauge-needle. The Control Group each of the 200 lymph nodes were sampled first with the 22 gauge- needles, then the 25 gauge-needle. Sample adequacy was assessed after 2 passes using each needle in all participants and recorded.</description>
        <time_frame>One to two hours.</time_frame>
        <population>All participants underwent sampling with both needles.</population>
        <group_list>
          <group group_id="O1">
            <title>Intervention Group: First Using a 25-gauge Needle Then 22-gauge Needle</title>
            <description>Participants in this group had their lymph nodes sampled with 25-gauge needle first followed by the 22-gauge needle.</description>
          </group>
          <group group_id="O2">
            <title>Control Group: First Using a 22-gauge Needle Then 25-gauge Needle</title>
            <description>Participants in this group had their lymph nodes sampled with 22-gauge needle first followed by the 25-gauge needle.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Lymph Nodes With Adequate Samples</title>
          <description>The primary outcome was the proportion of concordance between the 22-gauge and 25-gauge needles in sample adequacy after two passes. The intervention group each of the lymph nodes sampled first with 25 gauge-needle, then the 22 gauge-needle. The Control Group each of the 200 lymph nodes were sampled first with the 22 gauge- needles, then the 25 gauge-needle. Sample adequacy was assessed after 2 passes using each needle in all participants and recorded.</description>
          <population>All participants underwent sampling with both needles.</population>
          <units>Percentage of Lymph Nodes</units>
          <param>Number</param>
          <units_analyzed>Lymph Nodes</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="31"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Lymph Nodes</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="200"/>
                <count group_id="O2" value="200"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="79"/>
                    <measurement group_id="O2" value="78.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Concordance With the Final Diagnosis</title>
        <description>The difference in the diagnostic yield between the 22-gauge and 25-gauge needles in terms of degree of concordance with the final diagnosis. The intervention group each of the lymph nodes sampled first with 25 gauge-needle, then the 22 gauge-needle. The Control Group each of the 200 lymph nodes were sampled first with the 22 gauge- needles, then the 25 gauge-needle. The percentage of concordance was calculated by comparing the 2 passes from each needle to the final diagnosis.</description>
        <time_frame>One to two hours</time_frame>
        <population>All participants underwent sampling with both needles.</population>
        <group_list>
          <group group_id="O1">
            <title>Intervention Group: First Using a 25-gauge Needle Then 22-gauge Needle</title>
            <description>Participants in this group had their lymph nodes sampled with 25-gauge needle first followed by the 22-gauge needle.</description>
          </group>
          <group group_id="O2">
            <title>Control Group: First Using a 22-gauge Needle Then 25-gauge Needle</title>
            <description>Participants in this group had their lymph nodes sampled with 22-gauge needle first followed by the 25-gauge needle.</description>
          </group>
        </group_list>
        <measure>
          <title>Concordance With the Final Diagnosis</title>
          <description>The difference in the diagnostic yield between the 22-gauge and 25-gauge needles in terms of degree of concordance with the final diagnosis. The intervention group each of the lymph nodes sampled first with 25 gauge-needle, then the 22 gauge-needle. The Control Group each of the 200 lymph nodes were sampled first with the 22 gauge- needles, then the 25 gauge-needle. The percentage of concordance was calculated by comparing the 2 passes from each needle to the final diagnosis.</description>
          <population>All participants underwent sampling with both needles.</population>
          <units>Percentage of concordance</units>
          <param>Number</param>
          <units_analyzed>Lymph Nodes</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="31"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Lymph Nodes</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="200"/>
                <count group_id="O2" value="200"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="82"/>
                    <measurement group_id="O2" value="80.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Usability of the Needle</title>
        <description>The difference in usability between the 22-gauge and 25-gauge needles. All participant's lymph nodes were sampled by two 25-gauge needles and two 22-gauge needles for a total of 4 needles per person. Measured by a Likert scale 1-5 with 1 being the lowest and 5 being the maximum score. The intervention group each of the lymph nodes sampled first with 25 gauge-needle, then the 22 gauge-needle. The Control Group each of the 200 lymph nodes were sampled first with the 22 gauge- needles, then the 25 gauge-needle. The participants are reported per intervention.</description>
        <time_frame>1-2 hours (Intra procedurally)</time_frame>
        <population>Participant's lymph nodes were sampled by two 25-gauge needles and two 22-gauge needles for a total of 4 needles per person.</population>
        <group_list>
          <group group_id="O1">
            <title>Intervention Group: First Using a 25-gauge Needle Then 22-gauge Needle</title>
            <description>Participants lymph nodes were sampled first by two 25-gauge needles then two 22-gauge needles for a total of 4 needles per person.</description>
          </group>
          <group group_id="O2">
            <title>Control Group: First Using a 22-gauge Needle Then 25-gauge Needle</title>
            <description>Participants lymph nodes were sampled first by two 22-gauge needles then two 25-gauge needles for a total of 4 needles per person.</description>
          </group>
        </group_list>
        <measure>
          <title>Usability of the Needle</title>
          <description>The difference in usability between the 22-gauge and 25-gauge needles. All participant's lymph nodes were sampled by two 25-gauge needles and two 22-gauge needles for a total of 4 needles per person. Measured by a Likert scale 1-5 with 1 being the lowest and 5 being the maximum score. The intervention group each of the lymph nodes sampled first with 25 gauge-needle, then the 22 gauge-needle. The Control Group each of the 200 lymph nodes were sampled first with the 22 gauge- needles, then the 25 gauge-needle. The participants are reported per intervention.</description>
          <population>Participant's lymph nodes were sampled by two 25-gauge needles and two 22-gauge needles for a total of 4 needles per person.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <units_analyzed>Needles</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="61"/>
                <count group_id="O2" value="61"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Needles</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="122"/>
                <count group_id="O2" value="122"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Ease of needle insertion</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.27" spread="0.85"/>
                    <measurement group_id="O2" value="4.95" spread="0.20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visibility of the sheath</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.58" spread="0.65"/>
                    <measurement group_id="O2" value="4.00" spread="0.81"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Scope flexibility</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.40" spread="0.87"/>
                    <measurement group_id="O2" value="4.65" spread="0.64"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ultrasound image quality</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.62" spread="0.70"/>
                    <measurement group_id="O2" value="4.65" spread="0.65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ease of needle puncture</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.57" spread="0.75"/>
                    <measurement group_id="O2" value="4.53" spread="0.60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ultrasound image quality following needle insertion</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.62" spread="0.70"/>
                    <measurement group_id="O2" value="4.65" spread="0.65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ease of needle removal</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.71" spread="0.54"/>
                    <measurement group_id="O2" value="4.99" spread="0.11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>within 24 hours of procedure</time_frame>
      <desc>adverse events were monitored for irrespective of specific needle intervention and therefore cannot be reported separately</desc>
      <group_list>
        <group group_id="E1">
          <title>Intervention Group: First Using a 25-gauge Needle Then 22 Gauge-needle</title>
          <description>Participants lymph nodes sampled with 25-gauge needle first followed by the 22-gauge needle and sampled with 22-gauge needle first followed by the 25-gauge needle.</description>
        </group>
        <group group_id="E2">
          <title>Control Group: First Using a 22-gauge Needle Then 25 -Gauge Needle</title>
          <description>Patients in this group had their lymph nodes sampled with 22-gauge needle first followed by the 25-gauge needle.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>George Eapen,MD/ Professor, Pulmonary Medicine</name_or_title>
      <organization>UT MD Anderson Cancer Center</organization>
      <phone>(713) 563-4256</phone>
      <email>geapen@mdanderson.org</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03004586
org study id: 2016-0561
secondary id: NCI-2017-00624
nct id: NCT03004586
lead sponsor: 
collaborator: 
has dmc: No
The goal of this clinical research study is to compare the effectiveness of a smaller,
      25-gauge needle when used in an endobronchial ultrasound-guided transbronchial needle
      aspiration (EBUS-TBNA) instead of a standard 22-gauge needle.

      The safety of the needles will also be studied.
As a part of participant's standard-of-care, participant will have a bronchoscopy of lesions
      on participant's lung nodules and/or lymph nodes before the EBUS-TBNA. Participant will sign
      a separate consent for the bronchoscopy.

      If participant agrees to take part in this study, before participant's bronchoscopy,
      participant will be randomly assigned (as in the flip of a coin) to 1 of 2 study groups. This
      is done because no one knows if one study group is better, the same, or worse than the other
      group.

        -  If participant is in Group 1, participant will have the EBUS-TBNA performed by first
           using a 25-gauge needle, followed by a 22-gauge needle.

        -  If participant is in Group 2, participant will have the EBUS-TBNA performed by first
           using a 22-gauge needle, followed by a 25-gauge needle.

      To perform an EBUS-TBNA, a needle is inserted into the affected area using ultrasound imaging
      to collect tissue from the lungs and lymph nodes. The doctor will use the imaging to guide
      the needle into the area.

      Length of Study:

      Participation on the study will be over after the bronchoscopy and EBUS-TBNA.

      This is an investigational study. The 22-gauge and 25-gauge needles are FDA approved for use
      in EBUS-TBNAs. The comparison of the 2 needles for this procedure is investigational. The
      study doctor can explain how the needles are designed to work.

      Up to 120 participants will be enrolled in this study. All will take part at MD Anderson.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Diagnostic
masking: Double (Participant, Investigator)
measure: Percentage of Lymph Nodes With Adequate Samples
time frame: One to two hours.
description: The primary outcome was the proportion of concordance between the 22-gauge and 25-gauge needles in sample adequacy after two passes. The intervention group each of the lymph nodes sampled first with 25 gauge-needle, then the 22 gauge-needle. The Control Group each of the 200 lymph nodes were sampled first with the 22 gauge- needles, then the 25 gauge-needle. Sample adequacy was assessed after 2 passes using each needle in all participants and recorded.
measure: Concordance With the Final Diagnosis
time frame: One to two hours
description: The difference in the diagnostic yield between the 22-gauge and 25-gauge needles in terms of degree of concordance with the final diagnosis. The intervention group each of the lymph nodes sampled first with 25 gauge-needle, then the 22 gauge-needle. The Control Group each of the 200 lymph nodes were sampled first with the 22 gauge- needles, then the 25 gauge-needle. The percentage of concordance was calculated by comparing the 2 passes from each needle to the final diagnosis.
measure: Usability of the Needle
time frame: 1-2 hours (Intra procedurally)
description: The difference in usability between the 22-gauge and 25-gauge needles. All participant's lymph nodes were sampled by two 25-gauge needles and two 22-gauge needles for a total of 4 needles per person. Measured by a Likert scale 1-5 with 1 being the lowest and 5 being the maximum score. The intervention group each of the lymph nodes sampled first with 25 gauge-needle, then the 22 gauge-needle. The Control Group each of the 200 lymph nodes were sampled first with the 22 gauge- needles, then the 25 gauge-needle. The participants are reported per intervention.
arm group label: EBUS-TBNA:First Using a 25-Gauge Needle Then 22-gauge Needle
arm group type: Experimental
description: Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) performed by first using a 25-gauge needle, followed by a 22-gauge needle.
arm group label: EBUS-TBNA:First Using a 22-Gauge Needle Then 25-gauge Needle
arm group type: Experimental
description: Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) performed by first using a 22-gauge needle, followed by a 25-gauge needle.
intervention type: Device
intervention name: 25-Gauge Needle
description: Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) performed by using a 25-gauge needle.
arm group label: EBUS-TBNA:First Using a 22-Gauge Needle Then 25-gauge Needle
arm group label: EBUS-TBNA:First Using a 25-Gauge Needle Then 22-gauge Needle
intervention type: Device
intervention name: 22-Gauge Needle
description: Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) performed by using a 25-gauge needle.
arm group label: EBUS-TBNA:First Using a 22-Gauge Needle Then 25-gauge Needle
arm group label: EBUS-TBNA:First Using a 25-Gauge Needle Then 22-gauge Needle
intervention type: Procedure
intervention name: Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration (EBUS-TBNA)
description: Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) performed.
arm group label: EBUS-TBNA:First Using a 22-Gauge Needle Then 25-gauge Needle
arm group label: EBUS-TBNA:First Using a 25-Gauge Needle Then 22-gauge Needle
other name: EBUS-TBNA
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: George A. Eapen, MD
role: Principal Investigator
affiliation: M.D. Anderson Cancer Center
facility: 
country: United States
url: http://www.mdanderson.org
description: University of Texas MD Anderson Cancer Center Website
responsible party type: Sponsor
mesh term: Neoplasms
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 