TuberculosisNCT01350674
Role of EBUS-TBNA in Diagnosing TB in Mediastinal/Hilar Lymph Nodes
A study testing EBUS-TBNA in people with Tuberculosis, run by Centre Hospitalier Universitaire Saint Pierre at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tuberculosis
- What is being tested?
- EBUS-TBNA
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteBelgium
- Study dates
- Dec 2010to Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Role of EBUS-TBNA (Endobronchial Ultrasound Transbronchial Needle Aspiration- in Diagnosing Tuberculosis in Mediastinal and/or Hilar Lymph Nodes
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
- Being tested
- EBUS-TBNA
- Keywords
- mediastinal tuberculosis, endoscopy, EBUS, tuberculous lymphadenopathy, endobronchial ultrasound
- Medical subject headings
- Tuberculosis, Tuberculosis, Lymph Node
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EBUS-TBNAProcedure or surgery
endobronchial ultrasound transbronchial needle aspiration
| Study group | Role | What they receive |
|---|---|---|
| EBUS | Experimental | patients undergoing EBUS Receives: Procedure: EBUS-TBNA |
What is being measured
The primary outcome is the main question the study is designed to answer.
The ratio of tuberculosis in mediastinal lymph nodes
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2011 (estimated)
- Study startDec 2010
- Primary completionDec 2017
- Study completionMar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TuberculosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Saint Pierre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Inge M Muylle, MD, Principal investigator, CHU St. Pierre Brussels
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01350674
- Sponsor's protocol ID
- B07620109427
- Other IDs
- AK/10-10-3949/67
- Status last verified
- Oct 2017
- First submitted
- 28 Apr 2011
- Last updated
- 31 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of EBUS-TBNA (Endobronchial Ultrasound Transbronchial Needle Aspiration- in Diagnosing Tuberculosis in Mediastinal and/or Hilar Lymph Nodes
- ClinicalTrials.gov ID
- NCT01350674
- Acronym / sponsor ID
- B07620109427
- Conditions
- Tuberculosis
- Keywords
- mediastinal tuberculosis, endoscopy, EBUS, tuberculous lymphadenopathy, endobronchial ultrasound
- Study type
- Interventional
- Recruitment status
- Suspended
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire Saint PierreUniversity, hospital or other
- Study start
- Dec 2010
- Primary completion
- Dec 2017 (actual)
- Study completion
- Mar 2018
- First posted
- 10 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EBUS | Experimental | Procedure: EBUS-TBNApatients undergoing EBUS |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EBUS-TBNAendobronchial ultrasound transbronchial needle aspiration | Procedure or surgery | EBUS |
Primary outcome
The ratio of tuberculosis in mediastinal lymph nodes
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Inge M Muylle, MD principal investigator
CHU St. Pierre Brussels
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EBUS-TBNA in people with Tuberculosis, run by Centre Hospitalier Universitaire Saint Pierre at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 31 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The ratio of tuberculosis in mediastinal lymph nodes (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2018.