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Mediastinal Staging of Lung Cancer With EBUS-TBNA and EUS-B-FNA

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00741247
First Posted: August 26, 2008
Last Update Posted: June 24, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Cancer Center, Korea
  Purpose
The purpose of this study is to find a role of EUS-B-FNA in the mediastinal staging of potentially operable lung cancer. The investigators perform EBUS-TBNA and EUS-B-FNA on potentially operable lung cancer patients. The investigators perform EBUS(+/- TBNA) and EUS-B (ultrasonographic examination through the esophagus) on all subjects. EUS-B-FNA will be performed on inaccessible nodes or difficult nodes to be sampled by EBUS-TBNA. Additional diagnostic values of EUS-B-FNA as compared to EBUS-TBNA alone will be estimated.

Condition Intervention
Lung Cancer Procedure: EBUS-TBNA, EUS-B-FNA (EUS-FNA with bronchoscope)

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Minimally Invasive Mediastinal Staging of Potentially Operable Lung Cancer With Endobronchial Ultrasound Guided Transbronchial Needle Aspiration(EBUS-TBNA) and Transesophageal Aspiration Using Ultrasonic Bronchoscope (EUS-B-FNA)

Resource links provided by NLM:


Further study details as provided by National Cancer Center, Korea:

Primary Outcome Measures:
  • The diagnostic values of EBUS-TBNA plus EUS-B-FNA as compared to EBUS-TBNA alone [ Time Frame: June 2009 ]

Secondary Outcome Measures:
  • The Proportion and the location of lymph nodes accessible by EBUS-TBNA and EUS-B-FNA. [ Time Frame: June 2009 ]

Enrollment: 150
Study Start Date: August 2008
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: EBUS-TBNA, EUS-B-FNA (EUS-FNA with bronchoscope)
    EBUS-TBNA is a bronchoscopic diagnostic method that enables real time aspiration of paratracheal and peribronchial lesions. EUS-FNA is a procedure to obtain samples through the esophagus under real-time ultrasound guidance. In this study, EUS-FNA will be applied using a ultrasonic bronchoscope (EUS-B-FNA).
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically confirmed or strongly suspected potentially operable non-small cell lung cancer (NSCLC)
  • Potentially operable patients

Exclusion Criteria:

After staging work-up for NSCLC, including bronchoscopy,CT of the chest and upper abdomen, integrated PET/CT and brain MRI (and/or bone scan)

  • M1 disease
  • Inoperable T4 disease
  • Mediastinal infiltration or extranodal invasion of the mediastinal lymph node visible on chest CT.
  • Confirmed supraclavicular lymph node metastasis
  • Pancoast tumors
  • Medically inoperable patients
  • Contraindications for bronchoscopy
  Contacts and Locations
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): NCT00741247


Locations
Korea, Republic of
NCCKorea
Gyeonggi-do, Korea, Republic of
Sponsors and Collaborators
National Cancer Center, Korea
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: National Cancer Center, Korea
ClinicalTrials.gov Identifier: NCT00741247     History of Changes
Other Study ID Numbers: NCCCTS-08-332
First Submitted: August 25, 2008
First Posted: August 26, 2008
Last Update Posted: June 24, 2009
Last Verified: June 2009

Keywords provided by National Cancer Center, Korea:
staging
Endobronchial ultrasound
Endoscopic ultrasound

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