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

Not Applicable

Suspended

• Conditions: Tuberculosis
• Interventions: Procedure: EBUS-TBNA

• Registration Number: NCT01350674
• Lead Sponsor: Centre Hospitalier Universitaire Saint Pierre

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12
• Study First Submitted: 2011-04-28
• Study First Submitted QC: 2011-05-09
• Study First Posted: 2011-05-10
• Status Verified: 2017-10
• Primary Completion: 2017-12
• Study Completion: 2018-03
• Last Update Submitted: 2018-07-30
• Last Update Posted: 2018-07-31

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 50

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
EBUS	EBUS-TBNA	patients undergoing EBUS

Primary Outcome Measures

Name	Time	Method
The ratio of tuberculosis in mediastinal lymph nodes	8 weeks

Trial Locations

Locations (1)

CHU St. Pierre; pulmonology department; 🇧🇪 Brussels, Belgium