Trial Information
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)
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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Outcome Measure:
The diagnostic values of EBUS-TBNA plus EUS-B-FNA as compared to EBUS-TBNA alone
Outcome Time Frame:
June 2009
Safety Issue:
No
Authority:
South Korea: Korea Food and Drug Administration (KFDA)
Study ID:
NCCCTS-08-332
NCT ID:
NCT00741247
Start Date:
August 2008
Completion Date:
March 2009
Related Keywords:
- Lung Cancer
- staging
- Endobronchial ultrasound
- Endoscopic ultrasound
- Lung Neoplasms