Role of EBUS-TBNA in Diagnosing TB in Mediastinal/Hilar Lymph Nodes
This study is currently recruiting participants.
Verified October 2012 by Centre Hospitalier Universitaire Saint Pierre
Sponsor:
Centre Hospitalier Universitaire Saint Pierre
Information provided by (Responsible Party):
Centre Hospitalier Universitaire Saint Pierre
ClinicalTrials.gov Identifier:
NCT01350674
First received: April 28, 2011
Last updated: October 11, 2012
Last verified: October 2012
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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
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 11, 2012 |
| 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 May 16, 2013