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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by Centre Hospitalier Universitaire Saint Pierre
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire Saint Pierre
ClinicalTrials.gov Identifier:
NCT01350674
First received: April 28, 2011
Last updated: October 10, 2013
Last verified: October 2013
  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: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: December 2010
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: December 2015 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01350674

Contacts
Contact: Inge M Muylle, MD +3225354295 inge_muylle@stpieter-bru.be
Contact: Vincent Ninane, PhD MD +3225354276 vincent_ninane@stpierre-bru.be

Locations
Belgium
CHU St. Pierre; pulmonology department Recruiting
Brussels, Belgium, 1000
Contact: Inge M Muylle, MD    +3225354295    inge_muylle@stpieter-bru.be   
Contact: Vincent Ninane, PhD, MD    +3225354276    vincent_ninane@stpierre-bru.be   
Principal Investigator: Inge M Muylle, MD         
Sponsors and Collaborators
Centre Hospitalier Universitaire Saint Pierre
Investigators
Principal Investigator: Inge M Muylle, MD CHU St. Pierre Brussels
  More Information

No publications provided

Responsible Party: Centre Hospitalier Universitaire Saint Pierre
ClinicalTrials.gov Identifier: NCT01350674     History of Changes
Other Study ID Numbers: B07620109427, AK/10-10-3949/67
Study First Received: April 28, 2011
Last Updated: October 10, 2013
Health Authority: Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment

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

ClinicalTrials.gov processed this record on August 18, 2014