<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/NCT02245295</url>
  </required_header>
  <id_info>
    <org_study_id>EBUSEDA1</org_study_id>
    <nct_id>NCT02245295</nct_id>
  </id_info>
  <brief_title>The Role of Sedation Technique in EBUS-TBNA</brief_title>
  <official_title>Impact of Sedation Technique on the Diagnostic Accuracy of Endobronchial Ultrasound-guided Needle Aspiration (EBUS-TBNA)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Zurich</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Zurich</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      There is a paucity of data concerning the impact of the sedation technique used for&#xD;
      endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) on diagnostic&#xD;
      accuracy. The aim of this retrospective study is to compare diagnostic accuracy of EBUS-TBNA&#xD;
      in deep and moderate sedation, and to investigate other possible determinants of diagnostic&#xD;
      accuracy in three lymph node locations (mediastinal, subcarinal, and hilar).&#xD;
&#xD;
      The first consecutive patients at the University Hospital Zurich undergoing EBUS-TBNA for&#xD;
      selective sampling in deep sedation are compared with the first consecutive patients in&#xD;
      moderate sedation between 2006 and 2014. Diagnoses based on EBUS-TBNA were compared with&#xD;
      those on surgical or radiological follow-up.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Between September, 2007 and January 31, 2014, all consecutive patients who undergo EBUS-TBNA&#xD;
      at the University Hospital Zurich for selective assessment of enlarged (≥ 1 cm by CT or&#xD;
      ultrasound) or suspected (enhanced fluorodeoxyglucose (FDG) activity in PET/CT) lymph nodes&#xD;
      were enrolled. Demographic and clinical data, procedural reports and cytological findings&#xD;
      were collected from medical records. Computed tomography (CT) or PET/CT scans were&#xD;
      prospectively reviewed to gather the size and standardized uptake value (SUV) of FDG of each&#xD;
      sampled lymph node. The cytological findings obtained with EBUS-TBNA were verified by&#xD;
      histological examination, if a surgical biopsy (mediastinoscopy, thoracoscopy, or&#xD;
      thoracotomy) was carried out following EBUS-TBNA, or alternatively by clinical and&#xD;
      radiological follow-up data.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2014</start_date>
  <completion_date type="Actual">June 2014</completion_date>
  <primary_completion_date type="Actual">January 2014</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Diagnostic accuracy</measure>
    <time_frame>1-6 months</time_frame>
    <description>Sensitivity, negative predictive value</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Lymph node morphology</measure>
    <time_frame>1-6 months</time_frame>
    <description>Impact of lymph node size on diagnostic accuracy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>EBUS technique</measure>
    <time_frame>1-6 months</time_frame>
    <description>Impact of EBUS technique (number of needle passes) on diagnostic accuracy</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">232</enrollment>
  <condition>Lung Cancer</condition>
  <arm_group>
    <arm_group_label>EBUS-TBNA</arm_group_label>
    <description>EBUS-TBNA for enlarged mediastinal/hilar lymph nodes</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Moderate Sedation for EBUS/TBNA</intervention_name>
    <description>EBUS-TBNA was performed by one of the pulmonologists in moderate sedation (D.F., M.K.).</description>
    <arm_group_label>EBUS-TBNA</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>General anesthesia for EBUS/TBNA</intervention_name>
    <description>EBUS-TBNA was performedin general anaesthesia by one of the thoracic surgeons (D.S., P.K.)</description>
    <arm_group_label>EBUS-TBNA</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with enlarged or suspicious mediastinal and/or hilar lymph nodes, in whom&#xD;
        EBUS-TBNA is indicated&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  EBUS-TBNA&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  No exclusion criteria&#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>Daniel Franzen, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Division of Pulmonology</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Malcolm Kohler, Prof</last_name>
    <role>Study Chair</role>
    <affiliation>Division of Pulmonology</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital Zurich</name>
      <address>
        <city>Zurich</city>
        <zip>8091</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>September 15, 2014</study_first_submitted>
  <study_first_submitted_qc>September 16, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 19, 2014</study_first_posted>
  <last_update_submitted>November 14, 2016</last_update_submitted>
  <last_update_submitted_qc>November 14, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 15, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Bronchial endoscopy</keyword>
  <keyword>ultrasound</keyword>
  <keyword>EBUS</keyword>
  <keyword>anesthesia</keyword>
  <keyword>lung cancer</keyword>
  <keyword>diagnosis including staging</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anesthetics</mesh_term>
  </intervention_browse>
  <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/NCT02245295
org study id: EBUSEDA1
nct id: NCT02245295
lead sponsor: 
has dmc: Yes
There is a paucity of data concerning the impact of the sedation technique used for
      endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) on diagnostic
      accuracy. The aim of this retrospective study is to compare diagnostic accuracy of EBUS-TBNA
      in deep and moderate sedation, and to investigate other possible determinants of diagnostic
      accuracy in three lymph node locations (mediastinal, subcarinal, and hilar).

      The first consecutive patients at the University Hospital Zurich undergoing EBUS-TBNA for
      selective sampling in deep sedation are compared with the first consecutive patients in
      moderate sedation between 2006 and 2014. Diagnoses based on EBUS-TBNA were compared with
      those on surgical or radiological follow-up.
Between September, 2007 and January 31, 2014, all consecutive patients who undergo EBUS-TBNA
      at the University Hospital Zurich for selective assessment of enlarged (≥ 1 cm by CT or
      ultrasound) or suspected (enhanced fluorodeoxyglucose (FDG) activity in PET/CT) lymph nodes
      were enrolled. Demographic and clinical data, procedural reports and cytological findings
      were collected from medical records. Computed tomography (CT) or PET/CT scans were
      prospectively reviewed to gather the size and standardized uptake value (SUV) of FDG of each
      sampled lymph node. The cytological findings obtained with EBUS-TBNA were verified by
      histological examination, if a surgical biopsy (mediastinoscopy, thoracoscopy, or
      thoracotomy) was carried out following EBUS-TBNA, or alternatively by clinical and
      radiological follow-up data.
observational model: Case-Control
time perspective: Retrospective
measure: Diagnostic accuracy
time frame: 1-6 months
description: Sensitivity, negative predictive value
measure: Lymph node morphology
time frame: 1-6 months
description: Impact of lymph node size on diagnostic accuracy
measure: EBUS technique
time frame: 1-6 months
description: Impact of EBUS technique (number of needle passes) on diagnostic accuracy
arm group label: EBUS-TBNA
description: EBUS-TBNA for enlarged mediastinal/hilar lymph nodes
intervention type: Procedure
intervention name: Moderate Sedation for EBUS/TBNA
description: EBUS-TBNA was performed by one of the pulmonologists in moderate sedation (D.F., M.K.).
arm group label: EBUS-TBNA
intervention type: Procedure
intervention name: General anesthesia for EBUS/TBNA
description: EBUS-TBNA was performedin general anaesthesia by one of the thoracic surgeons (D.S., P.K.)
arm group label: EBUS-TBNA
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Daniel Franzen, MD
role: Principal Investigator
affiliation: Division of Pulmonology
last name: Malcolm Kohler, Prof
role: Study Chair
affiliation: Division of Pulmonology
facility: 
country: Switzerland
responsible party type: Sponsor
mesh term: Lung Neoplasms
mesh term: Anesthetics
sharing ipd: No