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

NCT01121432 | Unknown

• 1 other identifier: 201003061R
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Mediastinal Lymphadenopathy; Tuberculous Mediastinal Lymphadenopathy

Outcome Measures

Primary Outcomes (1)

• The ratio of tuberculous mediastinal lymphadenopathy

  4 weeks

Study Arms (1)

Mediastinal lymphadenopathy

Procedure: endobronchial ultrasound-guided transbronchial needle aspiration

Interventions

endobronchial ultrasound-guided transbronchial needle aspiration PROCEDURE

One time for aspiration/biopsy. The duration about 1-2 hour.

Mediastinal lymphadenopathy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The patients with mediastinal lymphadenopathy of unknow etiology

You may qualify if:

• All patients with mediastinal lymphadenopathy of unknown etiology
• All patients signed informed consent before the procedure.

You may not qualify if:

• Age less than 18 years
• Bleeding diathesis (INR\>1.4 or platelet count\<10k/mcl)

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Mediastinal lymph nodes

Study Officials

• Chao-Chi Ho, PhD

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Li-Ta Keng, MD

CONTACT

886-972652036; ltkeng@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 10, 2010
• First Posted: May 12, 2010
• Study Start: April 1, 2010
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: May 12, 2010

Record last verified: 2010-04

Locations

TW (1)