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Clinical Trial Details — Status: Suspended

Administrative data

NCT number NCT01350674
Other study ID # B07620109427
Secondary ID AK/10-10-3949/67
Status Suspended
Phase N/A
First received
Last updated
Start date December 2010
Est. completion date March 2018

Study information

Verified date October 2017
Source Centre Hospitalier Universitaire Saint Pierre
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Suspended
Enrollment 50
Est. completion date March 2018
Est. primary completion date December 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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)

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
EBUS-TBNA
endobronchial ultrasound transbronchial needle aspiration

Locations

Country Name City State
Belgium CHU St. Pierre; pulmonology department Brussels

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire Saint Pierre

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary The ratio of tuberculosis in mediastinal lymph nodes 8 weeks
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