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

Tuberculosis Clinical Trial

Official title:

Role of EBUS-TBNA (Endobronchial Ultrasound Transbronchial Needle Aspiration- in Diagnosing Tuberculosis in Mediastinal and/or Hilar Lymph Nodes

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
• 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
• 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)

Related Conditions & MeSH terms

• Tuberculosis

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