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NCT01493739 Clinical Trial

EBUS-TBNA for Diagnosis of Mediastinal Lymphadenopathy

Lung Cancer Clinical Trial

Official title:
EBUS-TBNA for Diagnosis of Mediastinal Lymphadenopathy

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01493739
Other study ID # EBUSTBNA_01
Secondary ID
Status Recruiting
Phase N/A
First received November 21, 2011
Last updated December 15, 2011
Start date January 2009
Est. completion date January 2012

Study information
Verified date December 2011
Source Chang Gung Memorial Hospital
Contact Chih-Hsi Kuo, MD
Email chihhsikuo@gmail.com
Is FDA regulated No
Health authority Taiwan: Department of Health
Study type Observational

Clinical Trial Summary

This study aims on the combinatorial results of cytology, histopathology and microbiology obatined by EBUS-TBNA for unselected mediastina lesions.

Description:

A number of studies have proved EBUS-TBNA to be useful for lymph node staging in lung cancer. The diagnostic performance is equivalent to mediastinoscopy while the invasiveness is far less. This study primarily focusing on merged approach of cytology, histopathology and microbioloogy obatined by EBUS-TBNA for unselected mediastina lesions.

Recruitment information / eligibility
Status Recruiting
Enrollment 100
Est. completion date January 2012
Est. primary completion date January 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 90 Years
Eligibility Inclusion Criteria:

- Age > 18 years old

- mediastinal lymphadenopathy on Chest CT scan

- with a short-axis > 10mm

Exclusion Criteria:

- patients intolerant to bronchoscopy exam

- unstable vital sign (Blood pressure, heart rate, breath rate)

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Taiwan Chang Gung Memorial Hospital Taipei

Sponsors (1)
Lead Sponsor Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Diagnostic rate Participant will be followed within an average of three months Yes
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