<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/NCT03232684</url>
  </required_header>
  <id_info>
    <org_study_id>CE 17021</org_study_id>
    <nct_id>NCT03232684</nct_id>
  </id_info>
  <brief_title>Rapid On-site Evaluation of Endobronchial Ultrasound Guided Transbronchial Needle Aspiration Samples by Pulmonologists</brief_title>
  <official_title>Rapid On-site Evaluation of EBUS-TBNA Samples From Intrathoracic Lymphadenopathy; Can it be Reliably Performed by a Pulmonologist?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Maggiore Bellaria Hospital, Bologna</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Maggiore Bellaria Hospital, Bologna</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 study is aimed at verifying if a pulmonologist in training can reliably assess the&#xD;
      adequacy of EBUS-TBNA samples from intrathoracic lymphadenopathy after a period of training&#xD;
      provided by an experienced pathologist.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 1, 2017</start_date>
  <completion_date type="Actual">June 30, 2018</completion_date>
  <primary_completion_date type="Actual">May 31, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Accuracy with which the pulmonologist will identify inadequate EBUS-TBNA samples</measure>
    <time_frame>Up to 1 week</time_frame>
    <description>The Outcome 1 will be measured by verifying the agreement between the pulmonologist judgment and the pathologist judgment, the latter being the gold standard</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Accuracy with which the pulmonologist will be able, in case of adequate EBUS-TBNA sample, to assign the specimen to one of the following specific diagnoses: 1) reactive lymph node; 2) malignancy; 3) granulomatous inflammation</measure>
    <time_frame>Up to 1 week</time_frame>
    <description>The Outcome 1 will be measured by verifying the agreement between the pulmonologist judgment and the pathologist judgment, the latter being the gold standard</description>
  </secondary_outcome>
  <enrollment type="Actual">200</enrollment>
  <condition>Intrathoracic Lymphadenopathy</condition>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Rapid on-site evaluation</intervention_name>
    <description>On-site (endoscopy suite) evaluation, by a pathologist or a pulmonologist, of specimens retrieved from intrathoracic lymph nodes during EBUS-TBNA</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with enlarged intratoracic lymph nodes&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Indication to sampling of intrathoracic lymphadenopathy based on computed tomography&#xD;
             (CT) and/or positron emission tomography (PET)/CT findings&#xD;
&#xD;
          -  Signed informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  High risk conditions for the performance of bronchoscopy and endobronchial ultrasound&#xD;
             guided transbronchial needle aspiration (EBUS-TBNA)&#xD;
&#xD;
          -  High risk condition for deep sedation (ASA 4)&#xD;
&#xD;
          -  Pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Rocco Trisolini, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Policlinico S. Orsola &amp; Maggiore Hospitals</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Maggiore Hospital</name>
      <address>
        <city>Bologna</city>
        <state>Emilia Romagna</state>
        <zip>40133</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <reference>
    <citation>Trisolini R, Cancellieri A, Tinelli C, Paioli D, Scudeller L, Casadei GP, Forti Parri S, Livi V, Bondi A, Boaron M, Patelli M. Rapid on-site evaluation of transbronchial aspirates in the diagnosis of hilar and mediastinal adenopathy: a randomized trial. Chest. 2011 Feb;139(2):395-401. doi: 10.1378/chest.10-1521. Epub 2010 Oct 28.</citation>
    <PMID>21030491</PMID>
  </reference>
  <results_reference>
    <citation>Bonifazi M, Sediari M, Ferretti M, Poidomani G, Tramacere I, Mei F, Zuccatosta L, Gasparini S. The role of the pulmonologist in rapid on-site cytologic evaluation of transbronchial needle aspiration: a prospective study. Chest. 2014 Jan;145(1):60-65. doi: 10.1378/chest.13-0756.</citation>
    <PMID>23846345</PMID>
  </results_reference>
  <verification_date>August 2018</verification_date>
  <study_first_submitted>July 21, 2017</study_first_submitted>
  <study_first_submitted_qc>July 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 28, 2017</study_first_posted>
  <last_update_submitted>August 17, 2018</last_update_submitted>
  <last_update_submitted_qc>August 17, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">August 20, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>IRCCS Azienda Ospedaliero-Universitaria di Bologna</investigator_affiliation>
    <investigator_full_name>Rocco Trisolini</investigator_full_name>
    <investigator_title>Director, Interventional Pulmonology Unit</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lymphadenopathy</mesh_term>
  </condition_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/NCT03232684
org study id: CE 17021
nct id: NCT03232684
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The study is aimed at verifying if a pulmonologist in training can reliably assess the
      adequacy of EBUS-TBNA samples from intrathoracic lymphadenopathy after a period of training
      provided by an experienced pathologist.
observational model: Cohort
time perspective: Prospective
measure: Accuracy with which the pulmonologist will identify inadequate EBUS-TBNA samples
time frame: Up to 1 week
description: The Outcome 1 will be measured by verifying the agreement between the pulmonologist judgment and the pathologist judgment, the latter being the gold standard
measure: Accuracy with which the pulmonologist will be able, in case of adequate EBUS-TBNA sample, to assign the specimen to one of the following specific diagnoses: 1) reactive lymph node; 2) malignancy; 3) granulomatous inflammation
time frame: Up to 1 week
description: The Outcome 1 will be measured by verifying the agreement between the pulmonologist judgment and the pathologist judgment, the latter being the gold standard
intervention type: Diagnostic Test
intervention name: Rapid on-site evaluation
description: On-site (endoscopy suite) evaluation, by a pathologist or a pulmonologist, of specimens retrieved from intrathoracic lymph nodes during EBUS-TBNA
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
last name: Rocco Trisolini, MD
role: Principal Investigator
affiliation: Policlinico S. Orsola & Maggiore Hospitals
facility: 
country: Italy
citation: Trisolini R, Cancellieri A, Tinelli C, Paioli D, Scudeller L, Casadei GP, Forti Parri S, Livi V, Bondi A, Boaron M, Patelli M. Rapid on-site evaluation of transbronchial aspirates in the diagnosis of hilar and mediastinal adenopathy: a randomized trial. Chest. 2011 Feb;139(2):395-401. doi: 10.1378/chest.10-1521. Epub 2010 Oct 28.
PMID: 21030491
citation: Bonifazi M, Sediari M, Ferretti M, Poidomani G, Tramacere I, Mei F, Zuccatosta L, Gasparini S. The role of the pulmonologist in rapid on-site cytologic evaluation of transbronchial needle aspiration: a prospective study. Chest. 2014 Jan;145(1):60-65. doi: 10.1378/chest.13-0756.
PMID: 23846345
responsible party type: Principal Investigator
investigator affiliation: IRCCS Azienda Ospedaliero-Universitaria di Bologna
investigator full name: Rocco Trisolini
investigator title: Director, Interventional Pulmonology Unit
mesh term: Lymphadenopathy
sharing ipd: No