<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/NCT02201654</url>
  </required_header>
  <id_info>
    <org_study_id>NA_00093452</org_study_id>
    <nct_id>NCT02201654</nct_id>
  </id_info>
  <brief_title>Stylet vs No Stylet During EBUS TBNA</brief_title>
  <official_title>Stylet Versus no Stylet in Endobronchial Ultrasound Transbronchial Aspiration (EBUS-TBNA)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Johns Hopkins University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Johns Hopkins University</source>
  <brief_summary>
    <textblock>
      This research study compares two ways to biopsy lymph nodes in the chest using endobronchial&#xD;
      ultrasound-guided transbronchial needle aspiration&quot; (EBUS-TNBA). During a EBUS-TBNA&#xD;
      procedure, the patient is sedated, and a flexible camera and ultrasound probe is inserted&#xD;
      through the mouth into the large airways of the chest, allowing us to see (via ultrasound)&#xD;
      and biopsy the lymph nodes in the chest.&#xD;
&#xD;
      The purpose of this research study is to determine if the EBUS-TBNA procedure can be made&#xD;
      simpler. In today's practice, the biopsy needle has two parts, 1) the needle itself and 2) an&#xD;
      inner stylet that runs through the middle of the needle. Because many other biopsy needles&#xD;
      (such as the needles used in breast biopsy and different types of lung biopsy needles) do not&#xD;
      use an inner stylet, the investigators do not think the use of a stylet is necessary. If this&#xD;
      step can be safely eliminated without decreasing the effectiveness of the procedure, this&#xD;
      could shorten the procedure (saving time). This study is deigned to formally test the&#xD;
      hypothesis that a stylet is not necessary in EBUS-TBNA.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>June 2014</start_date>
  <completion_date type="Actual">September 2015</completion_date>
  <primary_completion_date type="Actual">September 2015</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 agreement (percentage of samples that have the same diagnosis)</measure>
    <time_frame>At time of biopsy</time_frame>
    <description>The main outcome is the agreement (concordance) between the pathological diagnosis obtained by preforming EBUS with a stylet with EBUS without a stylet. Each patient will receive both techniques on each lymph node. We will then compare the diagnostic reached by each technique, and calculate the percentage of the time these techniques result in the same diagnosis.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pneumothorax rate (percentage of procedures that result in a pneumothorax)</measure>
    <time_frame>1 week post-procedure</time_frame>
    <description>Complications related to EBUS-TBNA are very rare, and are not anticipated to be higher due to enrollment in this study. We will track complications such as excessive bleeding, pneumothorax, and unanticipated admission to the hospital</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bleeding rate (% of procedures that have significant bleeding)</measure>
    <time_frame>1 week post-procedure</time_frame>
    <description>Complications related to EBUS-TBNA are very rare, and are not anticipated to be higher due to enrollment in this study. We will track complications such as excessive bleeding, pneumothorax, and unanticipated admission to the hospital</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital Admission (% of procedures that result in unanticipated admission to the hospital)</measure>
    <time_frame>1 week post-procedure</time_frame>
    <description>Complications related to EBUS-TBNA are very rare, and are not anticipated to be higher due to enrollment in this study. We will track complications such as excessive bleeding, pneumothorax, and unanticipated admission to the hospital</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">121</enrollment>
  <condition>Interstitial Lung Disease</condition>
  <arm_group>
    <arm_group_label>EBUS patients</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>All patients in our study are in the same arm, as each patient serves as their own internal control. More specifically, each enrolled patient will receive both traditional EBUS (with the usage of stylet) and experimental EBUS (EBUS without a stylet) at each lymph node that is included in the experimental analysis.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>EBUS without stylet</intervention_name>
    <description>the patient will receive both conventional ebus with the stylet and experimental ebus (without the stylet). The two techniques will then be compared to each other on a per lymph node basis.</description>
    <arm_group_label>EBUS patients</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All patients &gt;18 years old and capable of informed consent refereed for EBUS-TBNA at&#xD;
             our institution.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Standard contraindications to EBUS (coagulopathy, anti-platlet/anti-coagulant use,&#xD;
             clinical instability)&#xD;
&#xD;
          -  Pregnant women&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Johns Hopkins Hospital</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21218</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>June 5, 2014</study_first_submitted>
  <study_first_submitted_qc>July 25, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 28, 2014</study_first_posted>
  <last_update_submitted>December 14, 2016</last_update_submitted>
  <last_update_submitted_qc>December 14, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 15, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Diseases</mesh_term>
    <mesh_term>Lung Diseases, Interstitial</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/NCT02201654
org study id: NA_00093452
nct id: NCT02201654
lead sponsor: 
This research study compares two ways to biopsy lymph nodes in the chest using endobronchial
      ultrasound-guided transbronchial needle aspiration" (EBUS-TNBA). During a EBUS-TBNA
      procedure, the patient is sedated, and a flexible camera and ultrasound probe is inserted
      through the mouth into the large airways of the chest, allowing us to see (via ultrasound)
      and biopsy the lymph nodes in the chest.

      The purpose of this research study is to determine if the EBUS-TBNA procedure can be made
      simpler. In today's practice, the biopsy needle has two parts, 1) the needle itself and 2) an
      inner stylet that runs through the middle of the needle. Because many other biopsy needles
      (such as the needles used in breast biopsy and different types of lung biopsy needles) do not
      use an inner stylet, the investigators do not think the use of a stylet is necessary. If this
      step can be safely eliminated without decreasing the effectiveness of the procedure, this
      could shorten the procedure (saving time). This study is deigned to formally test the
      hypothesis that a stylet is not necessary in EBUS-TBNA.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Diagnostic agreement (percentage of samples that have the same diagnosis)
time frame: At time of biopsy
description: The main outcome is the agreement (concordance) between the pathological diagnosis obtained by preforming EBUS with a stylet with EBUS without a stylet. Each patient will receive both techniques on each lymph node. We will then compare the diagnostic reached by each technique, and calculate the percentage of the time these techniques result in the same diagnosis.
measure: Pneumothorax rate (percentage of procedures that result in a pneumothorax)
time frame: 1 week post-procedure
description: Complications related to EBUS-TBNA are very rare, and are not anticipated to be higher due to enrollment in this study. We will track complications such as excessive bleeding, pneumothorax, and unanticipated admission to the hospital
measure: Bleeding rate (% of procedures that have significant bleeding)
time frame: 1 week post-procedure
description: Complications related to EBUS-TBNA are very rare, and are not anticipated to be higher due to enrollment in this study. We will track complications such as excessive bleeding, pneumothorax, and unanticipated admission to the hospital
measure: Hospital Admission (% of procedures that result in unanticipated admission to the hospital)
time frame: 1 week post-procedure
description: Complications related to EBUS-TBNA are very rare, and are not anticipated to be higher due to enrollment in this study. We will track complications such as excessive bleeding, pneumothorax, and unanticipated admission to the hospital
arm group label: EBUS patients
arm group type: Other
description: All patients in our study are in the same arm, as each patient serves as their own internal control. More specifically, each enrolled patient will receive both traditional EBUS (with the usage of stylet) and experimental EBUS (EBUS without a stylet) at each lymph node that is included in the experimental analysis.
intervention type: Other
intervention name: EBUS without stylet
description: the patient will receive both conventional ebus with the stylet and experimental ebus (without the stylet). The two techniques will then be compared to each other on a per lymph node basis.
arm group label: EBUS patients
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor
mesh term: Lung Diseases
mesh term: Lung Diseases, Interstitial