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

• Sponsor: Centre Hospitalier Universitaire Saint Pierre (Other)
• Overall Status: Suspended
• CT.gov ID: NCT01350674
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Arm: 1
• Duration (Months): 87
• Patients Per Site Per Month: 0.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Tuberculosis	Procedure: EBUS-TBNA	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 50 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (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
• Study Start Date: Dec 1, 2010
• Actual Primary Completion Date: Dec 1, 2017
• Study Completion Date: Mar 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: EBUS patients undergoing EBUS	Procedure: EBUS-TBNA; endobronchial ultrasound transbronchial needle aspiration

Outcome Measures

Primary Outcome Measures

1. The ratio of tuberculosis in mediastinal lymph nodes [8 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	CHU St. Pierre; pulmonology department	Brussels		Belgium	1000

Sponsors and Collaborators

• Centre Hospitalier Universitaire Saint Pierre

Investigators

• Principal Investigator: Inge M Muylle, MD, CHU St. Pierre Brussels

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Centre Hospitalier Universitaire Saint Pierre
• ClinicalTrials.gov Identifier: NCT01350674
• Other Study ID Numbers: B07620109427; AK/10-10-3949/67
• First Posted: May 10, 2011
• Last Update Posted: Jul 31, 2018
• Last Verified: Oct 1, 2017

• Keywords provided by Centre Hospitalier Universitaire Saint Pierre: mediastinal tuberculosis; endoscopy; EBUS; tuberculous lymphadenopathy; endobronchial ultrasound
• Additional relevant MeSH terms: Tuberculosis

Study Results

No Results Posted as of Jul 31, 2018