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Role of EBUS-TBNA in Diagnosing TB in Mediastinal/Hilar Lymph Nodes

This study has suspended participant recruitment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01350674
First Posted: May 10, 2011
Last Update Posted: October 16, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Centre Hospitalier Universitaire Saint Pierre
  Purpose

This is an observational prospective study. Role of EBUS-TBNA (endobronchial ultrasound transbronchial needle aspiration) is evaluated to diagnose tuberculosis in mediastinal and/or hilar lymph nodes.

The investigators analyse the specificity and sensibility of this technique to diagnose tuberculosis in mediastinal and/or hilar lymph nodes.

Patients with mediastinal and/or hilar lymph nodes on X-ray or CT thorax where a tuberculosis is the most probable cause and who have no parenchymal lesions suspected for tuberculosis and without other lymph nodes that are more easily accessible or palpable will be included in this study.


Condition Intervention
Tuberculosis Procedure: EBUS-TBNA

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Role of EBUS-TBNA (Endobronchial Ultrasound Transbronchial Needle Aspiration- in Diagnosing Tuberculosis in Mediastinal and/or Hilar Lymph Nodes

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire Saint Pierre:

Primary Outcome Measures:
  • The ratio of tuberculosis in mediastinal lymph nodes [ Time Frame: 8 weeks ]

Estimated Enrollment: 50
Study Start Date: December 2010
Estimated Study Completion Date: March 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: EBUS
patients undergoing EBUS
Procedure: EBUS-TBNA
endobronchial ultrasound transbronchial needle aspiration

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients with enlarged mediastinal and/or hilar lymph nodes on chest CT highly suspicious of tuberculosis (suggestive clinical history, suggestive echographic findings ...) without pulmonary lesions suspicious for tuberculosis or in whom the first evaluation with sputum examination, classical bronchoscopy, induced sputum didn't result in any diagnosis.
  • patients aged 18 years or older
  • patients need to sign the consent form after reading the information form

Exclusion Criteria:

  • synchronic pulmonary lesions suspicious for tuberculosis or already proven tuberculosis by microscopic exam, PCR-technique and/or culture
  • other affected ganglionary sites more easily accessible (cervical, supraclavicular, axillary ... region)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01350674


Locations
Belgium
CHU St. Pierre; pulmonology department
Brussels, Belgium, 1000
Sponsors and Collaborators
Centre Hospitalier Universitaire Saint Pierre
Investigators
Principal Investigator: Inge M Muylle, MD CHU St. Pierre Brussels
  More Information

Responsible Party: Centre Hospitalier Universitaire Saint Pierre
ClinicalTrials.gov Identifier: NCT01350674     History of Changes
Other Study ID Numbers: B07620109427
AK/10-10-3949/67 ( Other Identifier: ethical committee UMC St Pieter Brussel Belgium )
First Submitted: April 28, 2011
First Posted: May 10, 2011
Last Update Posted: October 16, 2017
Last Verified: October 2017

Keywords provided by Centre Hospitalier Universitaire Saint Pierre:
mediastinal tuberculosis
endoscopy
EBUS
tuberculous lymphadenopathy
endobronchial ultrasound

Additional relevant MeSH terms:
Tuberculosis
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections