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

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.

Study Overview

• Status: Unknown
• Conditions: Mediastinal Lymphadenopathy; Tuberculous Mediastinal Lymphadenopathy
• Intervention / Treatment: Procedure: endobronchial ultrasound-guided transbronchial needle aspiration

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 Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 100
    • Recruiting
    • National Taiwan University Hospital
    • Contact: Chao-Chi Ho; Phone Number: 886-972651317; Email: ccho1203@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The patients with mediastinal lymphadenopathy of unknow etiology

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Mediastinal lymphadenopathy	Procedure: endobronchial ultrasound-guided transbronchial needle aspiration; One time for aspiration/biopsy. The duration about 1-2 hour.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The ratio of tuberculous mediastinal lymphadenopathy	4 weeks

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Investigators: Principal Investigator: Chao-Chi Ho, PhD, National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start: April 1, 2010
• Primary Completion (Anticipated): April 1, 2012
• Study Completion (Anticipated): April 1, 2012

Study Registration Dates

• First Submitted: May 10, 2010
• First Submitted That Met QC Criteria: May 11, 2010
• First Posted (Estimate): May 12, 2010

Study Record Updates

• Last Update Posted (Estimate): May 12, 2010
• Last Update Submitted That Met QC Criteria: May 11, 2010
• Last Verified: April 1, 2010

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Lymphatic Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Actinomycetales Infections; Mycobacterium Infections; Tuberculosis; Lymphadenopathy; Tuberculosis, Lymph Node
• Other Study ID Numbers: 201003061R