Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

EBUS-TBNA for Diagnosis of Mediastinal Lymphadenopathy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2011 by Chang Gung Memorial Hospital.
Recruitment status was  Recruiting
Information provided by (Responsible Party):
CHIH-HSI KUO, Chang Gung Memorial Hospital Identifier:
First received: November 21, 2011
Last updated: December 15, 2011
Last verified: December 2011

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

Mediastinal Lymphadenopathy
Lung Cancer

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: EBUS-TBNA for Diagnosis of Mediastinal Lymphadenopathy

Further study details as provided by Chang Gung Memorial Hospital:

Primary Outcome Measures:
  • Diagnostic rate [ Time Frame: Participant will be followed within an average of three months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 100
Study Start Date: January 2009
Estimated Study Completion Date: January 2012
Estimated Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)

Detailed 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.


Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients with mediastinal lymphadenopathy on Chest CT scan with a short-axis > 10mm


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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01493739

Contact: Chih-Hsi Kuo, MD
Contact: Fu-Tsai Chung, MD

Chang Gung Memorial Hospital Recruiting
Taipei, Taiwan, 112
Contact: Chih-Hsi Kuo, MD   
Principal Investigator: Chih-Hsi Kuo, MD         
Sponsors and Collaborators
Chang Gung Memorial Hospital
Principal Investigator: Chih-Hso Kuo, MD Chang Gung Memorial Hospital
  More Information

No publications provided

Responsible Party: CHIH-HSI KUO, Principle Investigator, Consultant Physician, Respiratory Medicine Department, Chang Gung Memorial Hospital Identifier: NCT01493739     History of Changes
Other Study ID Numbers: EBUSTBNA_01
Study First Received: November 21, 2011
Last Updated: December 15, 2011
Health Authority: Taiwan: Department of Health processed this record on February 27, 2015