An interventional study of EUS-B-FNA followed by EBUS-TBNA and EBUS-TBNA followed by EUS-B-FNA in Non Small Cell Lung Cancer, sponsored by National Cancer Center, Korea. Completed at 1 site in Korea, Republic of. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-10-18.
Sponsored by National Cancer Center, Korea · Not applicable, Interventional, and Diagnostic
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.
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This study's enrollment of 162 is above the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.
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Exclusion Criteria:
EBUS centered
Procedure: EUS-B-FNA followed by EBUS-TBNA
EUS centered
Procedure: EBUS-TBNA followed by EUS-B-FNA
EUS-B-FNA will be performed followed by EBUS-TBNA when additional needle aspiration is necessary after EBUS-TBNA.
EBUS-TBNA will be performed followed by EUS-B-FNA when additional needle aspiration is necessary after EUS-B-FNA
Diagnostic accuracy
Time frame: When the confimative disgnosis is available in all subjects (after surgery) ; 8-12 months
Procedure time
Time frame: During and just after the procedure ; 5-60 minutes
Cardiovascular measurement (change of blood pressure, changes of heart rate, number of patients with arrhythmia)
Time frame: During the procedure; 0-60 minutes
Degree of desaturation
Time frame: During the procedure; 0-60minutes
Discomfort by the procedure
Time frame: After the procedure ; 2-3hr
Number of participants with adverse Events (infection, bleeding requiring intervention, pneumothorax, or any complications requiring hospital admission)
Time frame: During and after the procedure; 0-2 weeks
Lymph node features
Time frame: During and after the procedure; 0-2hrs
Fentanyl/midazolam/lidocaine consumption
Time frame: After the procedure ; 1-2 hrs
This study is completed, as verified in Jun 2011. You cannot join it, but the record below documents what was studied.
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National Cancer Center, Korea