Back to resultsRole of EBUS-TBNA in Diagnosing TB in Mediastinal/Hilar Lymph Nodes
Primary Purpose
Tuberculosis
Status
Suspended
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
EBUS-TBNA
Sponsored by
About this trial
This is an interventional diagnostic trial for Tuberculosis focused on measuring mediastinal tuberculosis, endoscopy, EBUS, tuberculous lymphadenopathy, endobronchial ultrasound
Eligibility Criteria
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)
Sites / Locations
- CHU St. Pierre; pulmonology department
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
EBUS
Arm Description
patients undergoing EBUS
Outcomes
Primary Outcome Measures
The ratio of tuberculosis in mediastinal lymph nodes
Secondary Outcome Measures
Full Information
NCT ID
NCT01350674
First Posted
April 28, 2011
Last Updated
July 30, 2018
Sponsor
Centre Hospitalier Universitaire Saint Pierre
1. Study Identification
Unique Protocol Identification Number
NCT01350674
Brief Title
Role of EBUS-TBNA in Diagnosing TB in Mediastinal/Hilar Lymph Nodes
Official Title
Role of EBUS-TBNA (Endobronchial Ultrasound Transbronchial Needle Aspiration- in Diagnosing Tuberculosis in Mediastinal and/or Hilar Lymph Nodes
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Suspended
Study Start Date
December 2010 (undefined)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
March 2018 (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire Saint Pierre
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tuberculosis
Keywords
mediastinal tuberculosis, endoscopy, EBUS, tuberculous lymphadenopathy, endobronchial ultrasound
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
EBUS
Arm Type
Experimental
Arm Description
patients undergoing EBUS
Intervention Type
Procedure
Intervention Name(s)
EBUS-TBNA
Intervention Description
endobronchial ultrasound transbronchial needle aspiration
Primary Outcome Measure Information:
Title
The ratio of tuberculosis in mediastinal lymph nodes
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Inge M Muylle, MD
Organizational Affiliation
CHU St. Pierre Brussels
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU St. Pierre; pulmonology department
City
Brussels
ZIP/Postal Code
1000
Country
Belgium
12. IPD Sharing Statement
Learn more about this trial
Role of EBUS-TBNA in Diagnosing TB in Mediastinal/Hilar Lymph Nodes
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