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

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ClinicalTrials.gov Identifier: NCT00741247
Recruitment Status : Completed
First Posted : August 26, 2008
Last Update Posted : June 24, 2009
Information provided by:
National Cancer Center, Korea

Brief Summary:
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 or disease Intervention/treatment
Lung Cancer Procedure: EBUS-TBNA, EUS-B-FNA (EUS-FNA with bronchoscope)

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
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)
Study Start Date : August 2008
Primary Completion Date : March 2009
Study Completion Date : March 2009

Resource links provided by the National Library of Medicine

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

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).

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

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

Information from the National Library of Medicine

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

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

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

Korea, Republic of
Gyeonggi-do, Korea, Republic of
Sponsors and Collaborators
National Cancer Center, Korea

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 Posted: August 26, 2008    Key Record Dates
Last Update Posted: June 24, 2009
Last Verified: June 2009

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

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