Non Small Cell Lung Cancer
Conditions
Keywords
endobronchial ultrasound, endoscopic ultrasound, EBUS-TBNA, EUS-FNA, EUS-B-FNA, lung cancer, staging
Brief summary
This study aims to investigate a diagnostic yield and performance characteristics according to the order of endobronchial ultrasound guided transbronchial needle aspiration (EBUS-TBNA) and endoscopic ultrasound-with bronchoscope-guided transbronchial needle aspiration (EUS-B-FNA) in the mediastinal staging of potentially operable lung cancer. EUS-FNA is a better tolerated procedure than EBUS-TBNA. Therefore, EUS-B-FNA can be the main procedure in a combined approach with EBUS-TBNA and EUS-B-FNA. In group A, the investigators perform EBUS-TBNA first and EUS-B-FNA is performed when necessary. In group B, EUS-B-FNA is first applied and EBUS-TBNA is performed when necessary. The hypothesis is that the diagnostic yield of the EUS centered procedure is as good as that of the EBUS centered procedure and the EUS centered procedure is more tolerable than the EBUS centered procedure. We evaluate diagnostic yields and performance characteristics of each group.
Interventions
PROCEDUREEUS-B-FNA followed by EBUS-TBNA
EUS-B-FNA will be performed followed by EBUS-TBNA when additional needle aspiration is necessary after EBUS-TBNA.
PROCEDUREEBUS-TBNA followed by EUS-B-FNA
EBUS-TBNA will be performed followed by EUS-B-FNA when additional needle aspiration is necessary after EUS-B-FNA
Sponsors
National Cancer Center, Korea
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Diagnostic accuracy | When the confimative disgnosis is available in all subjects (after surgery) ; 8-12 months |
Secondary
| Measure | Time frame |
|---|---|
| Cardiovascular measurement (change of blood pressure, changes of heart rate, number of patients with arrhythmia) | During the procedure; 0-60 minutes |
| Degree of desaturation | During the procedure; 0-60minutes |
| Discomfort by the procedure | After the procedure ; 2-3hr |
| Procedure time | During and just after the procedure ; 5-60 minutes |
| Lymph node features | During and after the procedure; 0-2hrs |
| Fentanyl/midazolam/lidocaine consumption | After the procedure ; 1-2 hrs |
| Number of participants with adverse Events (infection, bleeding requiring intervention, pneumothorax, or any complications requiring hospital admission) | During and after the procedure; 0-2 weeks |
Countries
South Korea
Outcome results
None listed