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

This study has been completed.
Information provided by:
National Cancer Center, Korea Identifier:
First received: August 25, 2008
Last updated: June 23, 2009
Last verified: June 2009

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: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The Proportion and the location of lymph nodes accessible by EBUS-TBNA and EUS-B-FNA. [ Time Frame: June 2009 ] [ Designated as safety issue: No ]

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).

Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its identifier: NCT00741247

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

No publications provided by National Cancer Center, Korea

Additional publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: National Cancer Center, Korea Identifier: NCT00741247     History of Changes
Other Study ID Numbers: NCCCTS-08-332
Study First Received: August 25, 2008
Last Updated: June 23, 2009
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

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 processed this record on April 23, 2014