Mediastinal LymphadenopathyNCT01121432
Diagnosis of Mediastinal Tuberculous Lymphadenopathy by Endobronchial Ultrasound-guided Transbronchial Needle Aspiration (EBUS-TBNA)
An observational study of Mediastinal Lymphadenopathy and Tuberculous Mediastinal Lymphadenopathy, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Although mediastinal tuberculous lymphadenopathy is not rare in adults of such an abnormality. Isolated mediastinal without a parenchymal lung lesion in adults is unusual with the incidence of 0.25%-5.8%. It occurs most commonly in Asian and black people, and presents a diagnostic problem. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mediastinal Lymphadenopathy, Tuberculous Mediastinal Lymphadenopathy
- What is being tested?
- endobronchial ultrasound-guided transbronchial needle aspiration
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteTaiwan
- Study dates
- Apr 2010to Apr 2012
- Phase
- Observational
- 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
Study population: The patients with mediastinal lymphadenopathy of unknow etiology
Who may be able to join
- All patients with mediastinal lymphadenopathy of unknown etiology
- All patients signed informed consent before the procedure.
Who cannot join
- Age less than 18 years
- Bleeding diathesis (INR>1.4 or platelet count<10k/mcl)
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, 100
Chao-Chi Ho, 886-972651317, ccho1203@gmail.com
About this study
Although mediastinal tuberculous lymphadenopathy is not rare in adults of such an abnormality. Isolated mediastinal without a parenchymal lung lesion in adults is unusual with the incidence of 0.25%-5.8%. It occurs most commonly in Asian and black people, and presents a diagnostic problem. The definite diagnosis requires microbiology or pathology study.
Cervical mediastinoscopy remained the gold standard to sample the mediastnial lymph nodes, but this technique can access lymph node station 1-4, 7 only. EBUS-TBNA allows the mediastinal lymph nodes to be targeted in the areas accessible to cervical mediastinoscopy, as well as some hilar nodes (lymph node stations 2-4, 7, 10-12). Currently, the main indication of EBUS-TBNA is the mediastinal nodal staging of NSCLC after recent meta-analyses established the comparable sensitivity and specificity of nodal staging by EBUS-TBNA and cervical mediastinoscopy. Theoretically, mediastnial tuberculous lymphadenopathy could be diagnosed by the method of EBUS-TBNA. Douglas F. Johnson was the first doctor to report 2 cases of mediastinal tuberculous lymphadenopathy diagnosed by EBUS-TBNA in 2009. There are currently no much data on the use of this technique in this field. The investigators plan to perform a prospective single-center study to investigate the diagnostic efficacy of mediastinal tuberculous lymphadenopathy by sampling the culprit nodes via EBUS-TBNA. Concomitant sputum specimen for acid-fast stain and mycobacterial culture were collected as well.
Read the detailed description
Although mediastinal tuberculous lymphadenopathy is much more common as a manifestation of primary tuberculosis in children, the presentation in adults of such an abnormality is not rare. In a large series reported in 1959 by Lyons and coworkers, tuberculosis was the 5th commonest cause of mediastinal enlargement, accounting for 6% of 782 cases. Intrathoracic lymphadenitis had been found to be present in between 0.5% and 26%.
However, isolated mediastinal without a parenchymal lung lesion in adults is unusual with the incidence of 0.25%-5.8%. It occurs most commonly in Asian and black people, and presents a diagnostic problem. Although chest CT findings such as nodes with central low attenuation and peripheral rim enhancement are suggestive, the definite diagnosis requires microbiology or pathology study.
Cervical mediastinoscopy remained the gold standard to sample the mediastnial lymph nodes, but this technique can access lymph node station 1-4, 7 only. EBUS-TBNA allows the mediastinal lymph nodes to be targeted in the areas accessible to cervical mediastinoscopy, as well as some hilar nodes (lymph node stations 2-4, 7, 10-12).
Kazuhiro Yasufuku had published the first report of rear-time EBUS-TBNA in evaluating mediastinal lymphadenopathy in 2004. Currently, the main indication of EBUS-TBNA is the mediastinal nodal staging of NSCLC after recent meta-analyses established the comparable sensitivity and specificity of nodal staging by EBUS-TBNA and cervical mediastinoscopy. Efficacy in evaluation of other disease processes such as sarcoidosis and lymphoma has also been established.
Theoretically, mediastnial tuberculous lymphadenopathy could be diagnosed by the method of EBUS-TBNA. Douglas F. Johnson was the first doctor to report 2 cases of mediastinal tuberculous lymphadenopathy diagnosed by EBUS-TBNA in 2009. There are currently no much data on the use of this technique in this field.
We plan to perform a prospective single-center study to investigate the diagnostic efficacy of mediastinal tuberculous lymphadenopathy by sampling the culprit nodes via EBUS-TBNA. Concomitant sputum specimen for acid-fast stain and mycobacterial culture were collected as well.
- Being tested
- endobronchial ultrasound-guided transbronchial needle aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endobronchial ultrasound-guided transbronchial needle aspirationProcedure or surgery
One time for aspiration/biopsy. The duration about 1-2 hour.
| Study group | Role | What they receive |
|---|---|---|
| Mediastinal lymphadenopathy | Not described Receives: Procedure: endobronchial ultrasound-guided transbronchial needle aspiration |
What is being measured
The primary outcome is the main question the study is designed to answer.
The ratio of tuberculous mediastinal lymphadenopathy
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2010 (estimated)
- Study startApr 2010
- Primary completionApr 2012 (estimated)
- Study completionApr 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mediastinal LymphadenopathyStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Chao-Chi Ho, PhD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01121432
- Sponsor's protocol ID
- 201003061R
- Status last verified
- Apr 2010
- First submitted
- 10 May 2010
- Last updated
- 12 May 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnosis of Mediastinal Tuberculous Lymphadenopathy by Endobronchial Ultrasound-guided Transbronchial Needle Aspiration (EBUS-TBNA)
- ClinicalTrials.gov ID
- NCT01121432
- Acronym / sponsor ID
- 201003061R
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Apr 2012 (estimated)
- Study completion
- Apr 2012 (estimated)
- First posted
- 12 May 2010 (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.
Although mediastinal tuberculous lymphadenopathy is not rare in adults of such an abnormality. Isolated mediastinal without a parenchymal lung lesion in adults is unusual with the incidence of 0.25%-5.8%. It occurs most commonly in Asian and black people, and presents a diagnostic problem. The definite diagnosis requires microbiology or pathology study.
Cervical mediastinoscopy remained the gold standard to sample the mediastnial lymph nodes, but this technique can access lymph node station 1-4, 7 only. EBUS-TBNA allows the mediastinal lymph nodes to be targeted in the areas accessible to cervical mediastinoscopy, as well as some hilar nodes (lymph node stations 2-4, 7, 10-12). Currently, the main indication of EBUS-TBNA is the mediastinal nodal staging of NSCLC after recent meta-analyses established the comparable sensitivity and specificity of nodal staging by EBUS-TBNA and cervical mediastinoscopy. Theoretically, mediastnial tuberculous lymphadenopathy could be diagnosed by the method of EBUS-TBNA. Douglas F. Johnson was the first doctor to report 2 cases of mediastinal tuberculous lymphadenopathy diagnosed by EBUS-TBNA in 2009. There are currently no much data on the use of this technique in this field. The investigators plan to perform a prospective single-center study to investigate the diagnostic efficacy of mediastinal tuberculous lymphadenopathy by sampling the culprit nodes via EBUS-TBNA. Concomitant sputum specimen for acid-fast stain and mycobacterial culture were collected as well.
Detailed description
Although mediastinal tuberculous lymphadenopathy is much more common as a manifestation of primary tuberculosis in children, the presentation in adults of such an abnormality is not rare. In a large series reported in 1959 by Lyons and coworkers, tuberculosis was the 5th commonest cause of mediastinal enlargement, accounting for 6% of 782 cases. Intrathoracic lymphadenitis had been found to be present in between 0.5% and 26%.
However, isolated mediastinal without a parenchymal lung lesion in adults is unusual with the incidence of 0.25%-5.8%. It occurs most commonly in Asian and black people, and presents a diagnostic problem. Although chest CT findings such as nodes with central low attenuation and peripheral rim enhancement are suggestive, the definite diagnosis requires microbiology or pathology study.
Cervical mediastinoscopy remained the gold standard to sample the mediastnial lymph nodes, but this technique can access lymph node station 1-4, 7 only. EBUS-TBNA allows the mediastinal lymph nodes to be targeted in the areas accessible to cervical mediastinoscopy, as well as some hilar nodes (lymph node stations 2-4, 7, 10-12).
Kazuhiro Yasufuku had published the first report of rear-time EBUS-TBNA in evaluating mediastinal lymphadenopathy in 2004. Currently, the main indication of EBUS-TBNA is the mediastinal nodal staging of NSCLC after recent meta-analyses established the comparable sensitivity and specificity of nodal staging by EBUS-TBNA and cervical mediastinoscopy. Efficacy in evaluation of other disease processes such as sarcoidosis and lymphoma has also been established.
Theoretically, mediastnial tuberculous lymphadenopathy could be diagnosed by the method of EBUS-TBNA. Douglas F. Johnson was the first doctor to report 2 cases of mediastinal tuberculous lymphadenopathy diagnosed by EBUS-TBNA in 2009. There are currently no much data on the use of this technique in this field.
We plan to perform a prospective single-center study to investigate the diagnostic efficacy of mediastinal tuberculous lymphadenopathy by sampling the culprit nodes via EBUS-TBNA. Concomitant sputum specimen for acid-fast stain and mycobacterial culture were collected as well.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mediastinal lymphadenopathy | – | Procedure: endobronchial ultrasound-guided transbronchial needle aspiration |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The patients with mediastinal lymphadenopathy of unknow etiology
Key inclusion criteria (2 listed)
- All patients with mediastinal lymphadenopathy of unknown etiology
- All patients signed informed consent before the procedure.
Key exclusion criteria (2 listed)
- Age less than 18 years
- Bleeding diathesis (INR>1.4 or platelet count<10k/mcl)
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 |
|---|---|---|
| endobronchial ultrasound-guided transbronchial needle aspirationOne time for aspiration/biopsy. The duration about 1-2 hour. | Procedure or surgery | Mediastinal lymphadenopathy |
Primary outcome
The ratio of tuberculous mediastinal lymphadenopathy
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2010.
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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.
Chao-Chi Ho, PhD principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mediastinal Lymphadenopathy and Tuberculous Mediastinal Lymphadenopathy, run by National Taiwan University Hospital at 1 site in Taiwan.
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 2 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: status not confirmed, as of the sponsor's last update on 12 May 2010. 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 Taiwan. 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?
Contact Li-Ta Keng, MD (886-972652036, ltkeng@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The ratio of tuberculous mediastinal lymphadenopathy (time frame: 4 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 12 May 2010.