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

NCT01350674 | Suspended

• 2 other identifiers: B07620109427AK/10-10-3949/67
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Tuberculosis

Keywords

mediastinal tuberculosis; endoscopy; EBUS; tuberculous lymphadenopathy; endobronchial ultrasound

Outcome Measures

Primary Outcomes (1)

• The ratio of tuberculosis in mediastinal lymph nodes

  8 weeks

Study Arms (1)

EBUS

EXPERIMENTAL

patients undergoing EBUS

Procedure: EBUS-TBNA

Interventions

EBUS-TBNA PROCEDURE

endobronchial ultrasound transbronchial needle aspiration

EBUS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Centre Hospitalier Universitaire Saint Pierre: lead

Study Sites (1)

CHU St. Pierre; pulmonology department

Brussels, 1000, Belgium

Location

MeSH Terms

Conditions

Tuberculosis; Tuberculosis, Lymph Node

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Tuberculosis, Extrapulmonary

Study Officials

• Inge M Muylle, MD

  CHU St. Pierre Brussels

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2011
• First Posted: May 10, 2011
• Study Start: December 1, 2010
• Primary Completion: December 1, 2017
• Study Completion: March 1, 2018
• Last Updated: July 31, 2018

Record last verified: 2017-10

Locations

BE (1)