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EBUS-TBNA for Diagnosis of Mediastinal Lymphadenopathy

This study is currently recruiting participants.
Verified December 2011 by Chang Gung Memorial Hospital
Sponsor:
Information provided by (Responsible Party):
CHIH-HSI KUO, Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier:
NCT01493739
First received: November 21, 2011
Last updated: December 15, 2011
Last verified: December 2011
History of Changes
  Purpose

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


Condition
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer
U.S. FDA Resources

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)
Groups/Cohorts
lymphadenopathy

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.

  Eligibility

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

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01493739

Contacts
Contact: Chih-Hsi Kuo, MD chihhsikuo@gmail.com
Contact: Fu-Tsai Chung, MD

Locations
Taiwan
Chang Gung Memorial Hospital Recruiting
Taipei, Taiwan, 112
Contact: Chih-Hsi Kuo, MD         chihhsikuo@gmail.com    
Principal Investigator: Chih-Hsi Kuo, MD            
Sponsors and Collaborators
Chang Gung Memorial Hospital
Investigators
Principal Investigator: Chih-Hso Kuo, MD Chang Gung Memorial Hospital
  More Information

Publications:

Responsible Party: CHIH-HSI KUO, Principle Investigator, Consultant Physician, Respiratory Medicine Department, Chang Gung Memorial Hospital
ClinicalTrials.gov 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

Additional relevant MeSH terms:
Lung Neoplasms
Lymphatic Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
 Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 16, 2013