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

NCT ID: NCT01350674

Last Updated: 2018-07-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-12-31

Study Completion Date

2018-03-31

Brief Summary

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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

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Conditions

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Tuberculosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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EBUS

patients undergoing EBUS

Group Type EXPERIMENTAL

EBUS-TBNA

Intervention Type PROCEDURE

endobronchial ultrasound transbronchial needle aspiration

Interventions

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EBUS-TBNA

endobronchial ultrasound transbronchial needle aspiration

Intervention Type PROCEDURE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire Saint Pierre

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Inge M Muylle, MD

Role: PRINCIPAL_INVESTIGATOR

CHU St. Pierre Brussels

Locations

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CHU St. Pierre; pulmonology department

Brussels, , Belgium

Site Status

Countries

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Belgium

Other Identifiers

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AK/10-10-3949/67

Identifier Type: OTHER

Identifier Source: secondary_id

B07620109427

Identifier Type: -

Identifier Source: org_study_id

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