<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/NCT01734980</url>
  </required_header>
  <id_info>
    <org_study_id>11-018</org_study_id>
    <nct_id>NCT01734980</nct_id>
  </id_info>
  <brief_title>Endobronchial Ultrasound Transbronchial Needle Aspiration Using Needle Suction Versus No Suction</brief_title>
  <official_title>Comparison Of Cytologic Accuracy Of Endobronchial Ultrasound Transbronchial Needle Aspiration Using Needle Suction Versus No Suction</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Northwell Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Northwell Health</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Cytological diagnostic accuracy between endobronchial ultrasonography endobronchial&#xD;
      ultrasound transbronchial needle aspiration (EBUS-TBNA) samples using suction versus samples&#xD;
      when no suction is applied.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Endobronchial ultrasound-guided transbronchial needle aspiration which is known as the EBUS&#xD;
      procedure is a low risk procedure performed using bronchoscopy to sample chest lesions. A&#xD;
      needle is passed through the bronchoscope to biopsy the chest lesion. Every lesion is usually&#xD;
      biopsied 3 to 7 times. In most cases the investigators apply a syringe with negative pressure&#xD;
      to the needle inserted into lesion for biopsy. In some cases the investigators don't apply&#xD;
      any negative pressure. There are no studies to evaluate which one is better, applying syringe&#xD;
      suction or no suction.&#xD;
&#xD;
      In our study, the investigators are planning to do biopsies with or without suction. Then,&#xD;
      the pathology samples will be evaluated for any cytologic difference in making the diagnosis.&#xD;
      Any patient undergoing the EBUS procedure for chest biopsies will be eligible. Every lesion&#xD;
      will be biopsied at least twice with needle with and without suction. The biopsy samples will&#xD;
      be then divided into group A where the investigators applied syringe suction and group B&#xD;
      where no syringe suction was applied. There is no risk to the patient in addition to the risk&#xD;
      of the EBUS procedure itself. The investigators are not performing any additional&#xD;
      intervention from the usual standard of care for any patient presenting for the EBUS&#xD;
      procedure. Essentially the investigators are simply grouping the suction and no suction&#xD;
      pathology samples as A and B for pathologic comparison.&#xD;
&#xD;
      RESULTS: Among the 26 participants, one of the patients (3.8%) had no adequate tissue using&#xD;
      both methods; one patient (3.8%) had adequate tissue using suction but no adequate tissue&#xD;
      using no suction; and 24 patients had adequate tissue using both methods (92.3%, p= 1.00).&#xD;
      Among the twenty-four patients with adequate tissue using both methods, 14 patients (58.3%)&#xD;
      had benign pathology using both methods, while ten patients (41.7%) had malignant pathology&#xD;
      using both methods (p= 1.00). Considering suction to be the golden method, the sensitivity&#xD;
      and specificity of no suction were 100%. Among the 32 sites that were sampled, one site&#xD;
      (3.1%) had no adequate tissue using both methods; one site (3.1%) had adequate tissue using&#xD;
      suction but no adequate tissue using no suction; and 30 sites had adequate tissue using both&#xD;
      methods (93.8%, p= 1.00). Among the thirty sites with adequate tissue using both methods, 17&#xD;
      (56.7%) had benign pathology using both methods; 12 (40.0%) had malignant pathology using&#xD;
      both methods; and one site (3.3%) had malignant pathology using suction, but benign pathology&#xD;
      using no suction (p= 1.00). Considering suction to be the golden method, the no suction had a&#xD;
      sensitivity= 92.3% and specificity= 100%.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>February 2011</start_date>
  <completion_date type="Actual">November 2011</completion_date>
  <primary_completion_date type="Actual">November 2011</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>Diagnostic yield</measure>
    <time_frame>3 days</time_frame>
    <description>The number of patients with cytological diagnosis as a measure of effective diagnostic technique.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Samples adequacy</measure>
    <time_frame>3 days</time_frame>
    <description>adequate cytological material as a measure of effective diagnostic technique.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Mediastinal Lymphadenopathy</condition>
  <condition>Lung Malignancies</condition>
  <arm_group>
    <arm_group_label>Endobronchial Ultrasound</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>EBUS-TBNA is a procedure that allows accurate sampling of mediastinal lymph nodes and peribronchial lesions</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Endobronchial Ultrasound</intervention_name>
    <description>The samples will be divided as 2 groups for comparison. Group A is the group of samples where we apply negative pressure syringe for needle suction. Group B is where no suction will be applied after needle insertion.</description>
    <arm_group_label>Endobronchial Ultrasound</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All adult subjects who are scheduled to undergo endobronchial ultrasound&#xD;
             transbronchial aspiration to sample mediastinal masses or lymph nodes.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who are not able to complete the EBUS procedure for any reason&#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>Michel Chalhoub, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Staten Island University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Staten Island University Hospital</name>
      <address>
        <city>Staten Island</city>
        <state>New York</state>
        <zip>10305</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2012</verification_date>
  <study_first_submitted>July 4, 2012</study_first_submitted>
  <study_first_submitted_qc>November 25, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 28, 2012</study_first_posted>
  <last_update_submitted>November 25, 2012</last_update_submitted>
  <last_update_submitted_qc>November 25, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 28, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Northwell Health</investigator_affiliation>
    <investigator_full_name>Michel Chalhoub</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Endobronchial Ultrasound</keyword>
  <keyword>transbronchial needle aspiration</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lymphadenopathy</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/NCT01734980
org study id: 11-018
nct id: NCT01734980
lead sponsor: 
has dmc: No
Cytological diagnostic accuracy between endobronchial ultrasonography endobronchial
      ultrasound transbronchial needle aspiration (EBUS-TBNA) samples using suction versus samples
      when no suction is applied.
Endobronchial ultrasound-guided transbronchial needle aspiration which is known as the EBUS
      procedure is a low risk procedure performed using bronchoscopy to sample chest lesions. A
      needle is passed through the bronchoscope to biopsy the chest lesion. Every lesion is usually
      biopsied 3 to 7 times. In most cases the investigators apply a syringe with negative pressure
      to the needle inserted into lesion for biopsy. In some cases the investigators don't apply
      any negative pressure. There are no studies to evaluate which one is better, applying syringe
      suction or no suction.

      In our study, the investigators are planning to do biopsies with or without suction. Then,
      the pathology samples will be evaluated for any cytologic difference in making the diagnosis.
      Any patient undergoing the EBUS procedure for chest biopsies will be eligible. Every lesion
      will be biopsied at least twice with needle with and without suction. The biopsy samples will
      be then divided into group A where the investigators applied syringe suction and group B
      where no syringe suction was applied. There is no risk to the patient in addition to the risk
      of the EBUS procedure itself. The investigators are not performing any additional
      intervention from the usual standard of care for any patient presenting for the EBUS
      procedure. Essentially the investigators are simply grouping the suction and no suction
      pathology samples as A and B for pathologic comparison.

      RESULTS: Among the 26 participants, one of the patients (3.8%) had no adequate tissue using
      both methods; one patient (3.8%) had adequate tissue using suction but no adequate tissue
      using no suction; and 24 patients had adequate tissue using both methods (92.3%, p= 1.00).
      Among the twenty-four patients with adequate tissue using both methods, 14 patients (58.3%)
      had benign pathology using both methods, while ten patients (41.7%) had malignant pathology
      using both methods (p= 1.00). Considering suction to be the golden method, the sensitivity
      and specificity of no suction were 100%. Among the 32 sites that were sampled, one site
      (3.1%) had no adequate tissue using both methods; one site (3.1%) had adequate tissue using
      suction but no adequate tissue using no suction; and 30 sites had adequate tissue using both
      methods (93.8%, p= 1.00). Among the thirty sites with adequate tissue using both methods, 17
      (56.7%) had benign pathology using both methods; 12 (40.0%) had malignant pathology using
      both methods; and one site (3.3%) had malignant pathology using suction, but benign pathology
      using no suction (p= 1.00). Considering suction to be the golden method, the no suction had a
      sensitivity= 92.3% and specificity= 100%.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Diagnostic yield
time frame: 3 days
description: The number of patients with cytological diagnosis as a measure of effective diagnostic technique.
measure: Samples adequacy
time frame: 3 days
description: adequate cytological material as a measure of effective diagnostic technique.
arm group label: Endobronchial Ultrasound
arm group type: Experimental
description: EBUS-TBNA is a procedure that allows accurate sampling of mediastinal lymph nodes and peribronchial lesions
intervention type: Procedure
intervention name: Endobronchial Ultrasound
description: The samples will be divided as 2 groups for comparison. Group A is the group of samples where we apply negative pressure syringe for needle suction. Group B is where no suction will be applied after needle insertion.
arm group label: Endobronchial Ultrasound
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Michel Chalhoub, MD
role: Principal Investigator
affiliation: Staten Island University Hospital
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Northwell Health
investigator full name: Michel Chalhoub
investigator title: Principal Investigator
mesh term: Lymphadenopathy