EBUS-TBNA for Diagnosis of Mediastinal Lymphadenopathy

December 15, 2011 updated by: CHIH-HSI KUO, Chang Gung Memorial Hospital
This study aims on the combinatorial results of cytology, histopathology and microbiology obatined by EBUS-TBNA for unselected mediastina lesions.

Study Overview

Status

Unknown

Conditions

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

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Fu-Tsai Chung, MD

Study Locations

  • Taiwan
      • Taipei, Taiwan, 112
        • Recruiting
        • Chang Gung Memorial Hospital
        • Contact:
        • Principal Investigator:
          • Chih-Hsi Kuo, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
lymphadenopathy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Diagnostic rate
Time Frame: Participant will be followed within an average of three months
Participant will be followed within an average of three months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chang Gung Memorial Hospital

Investigators

  • Principal Investigator: Chih-Hso Kuo, MD, Chang Gung Memorial Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Anticipated)

January 1, 2012

Study Completion (Anticipated)

January 1, 2012

Study Registration Dates

First Submitted

November 21, 2011

First Submitted That Met QC Criteria

December 15, 2011

First Posted (Estimate)

December 16, 2011

Study Record Updates

Last Update Posted (Estimate)

December 16, 2011

Last Update Submitted That Met QC Criteria

December 15, 2011

Last Verified

December 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EBUSTBNA_01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Lung Cancer

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Malaysia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe