Trial Information
Combined Application of EBUS-TBNA and EUS-B-FNA in Mediastinal Staging of Lung Cancer; EBUS-TBNA Centered Procedure vs. EUS-B-FNA Centered Procedure, a Randomized Study.
Inclusion Criteria:
- Histologically confirmed or strongly suspected non-small cell lung cancer (NSCLC)
- Potentially operable patients
Exclusion Criteria:
- 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 and esophageal endoscopy
- Drug reaction to lidocaine, midazolam,fentanyl
- Pregnancy
- Ground glass-dominant nodule ( < 3cm)
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Diagnostic
Outcome Measure:
Diagnostic accuracy
Outcome Time Frame:
When the confimative disgnosis is available in all subjects (after surgery) ; 8-12 months
Safety Issue:
No
Principal Investigator
Bin Hwangbo, MD, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Medical Doctor, Senior Researcher
Authority:
Korea: Institutional Review Board
Study ID:
NCC-EUSEBUS
NCT ID:
NCT01385111
Start Date:
June 2011
Completion Date:
February 2012
Related Keywords:
- Non Small Cell Lung Cancer
- endobronchial ultrasound
- endoscopic ultrasound
- EBUS-TBNA
- EUS-FNA
- EUS-B-FNA
- lung cancer
- staging
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms