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EBUS-TBNA for Diagnosis of Mediastinal Lymphadenopathy

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ClinicalTrials.gov Identifier: NCT01493739
Recruitment Status : Unknown
Verified December 2011 by CHIH-HSI KUO, Chang Gung Memorial Hospital.
Recruitment status was:  Recruiting
First Posted : December 16, 2011
Last Update Posted : December 16, 2011
Sponsor:
Information provided by (Responsible Party):
CHIH-HSI KUO, Chang Gung Memorial Hospital

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

Condition or disease
Mediastinal Lymphadenopathy Lung Cancer

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.

Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: EBUS-TBNA for Diagnosis of Mediastinal Lymphadenopathy
Study Start Date : January 2009
Estimated Primary Completion Date : January 2012
Estimated Study Completion Date : January 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort
lymphadenopathy



Primary Outcome Measures :
  1. Diagnostic rate [ Time Frame: Participant will be followed within an average of three months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: December 16, 2011    Key Record Dates
Last Update Posted: December 16, 2011
Last Verified: December 2011

Additional relevant MeSH terms:
Lymphadenopathy
Lymphatic Diseases