Diagnosis of Mediastinal Tuberculous Lymphadenopathy by Endobronchial Ultrasound-guided Transbronchial Needle Aspiration (EBUS-TBNA)

Mediastinal Lymphadenopathy Clinical Trial

Official title:

Diagnosis of Mediastinal Tuberculous Lymphadenopathy by Endobronchial Ultrasound-guided Transbronchial Needle Aspiration (EBUS-TBNA)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01121432
• Other study ID #: 201003061R
• Status: Recruiting
• Phase: N/A
• First received: May 10, 2010
• Last updated: May 11, 2010
• Start date: April 2010
• Est. completion date: April 2012

Study information

• Verified date: April 2010
• Source: National Taiwan University Hospital
• Contact: Li-Ta Keng, MD
• Phone: 886-972652036
• Email: ltkeng[@]gmail.com
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. All patients with mediastinal lymphadenopathy of unknown etiology

2. All patients signed informed consent before the procedure.

Exclusion Criteria:

1. Age less than 18 years

2. Bleeding diathesis (INR>1.4 or platelet count<10k/mcl)

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Mediastinal Lymphadenopathy
• Tuberculosis
• Tuberculous Mediastinal Lymphadenopathy

Intervention

Procedure:
• endobronchial ultrasound-guided transbronchial needle aspiration
One time for aspiration/biopsy. The duration about 1-2 hour.

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The ratio of tuberculous mediastinal lymphadenopathy		4 weeks	No