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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A | Active Comparator | EBUS centered |
|
| Arm B | Experimental | EUS centered |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EUS-B-FNA followed by EBUS-TBNA | Procedure | EUS-B-FNA will be performed followed by EBUS-TBNA when additional needle aspiration is necessary after EBUS-TBNA. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic accuracy | When the confimative disgnosis is available in all subjects (after surgery) ; 8-12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Procedure time | During and just after the procedure ; 5-60 minutes | |
| Cardiovascular measurement (change of blood pressure, changes of heart rate, number of patients with arrhythmia) | During the procedure; 0-60 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bin Hwangbo, MD, PhD | Medical Doctor, Senior Researcher | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Cancer Center (NCC) Korea | Goyang-si | Gyeonggi-do | 410-769 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24172712 | Derived | Kang HJ, Hwangbo B, Lee GK, Nam BH, Lee HS, Kim MS, Lee JM, Zo JI, Lee HS, Han JY. EBUS-centred versus EUS-centred mediastinal staging in lung cancer: a randomised controlled trial. Thorax. 2014 Mar;69(3):261-8. doi: 10.1136/thoraxjnl-2013-203881. Epub 2013 Oct 30. |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
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| EBUS-TBNA followed by EUS-B-FNA | Procedure | EBUS-TBNA will be performed followed by EUS-B-FNA when additional needle aspiration is necessary after EUS-B-FNA |
|
| Degree of desaturation | During the procedure; 0-60minutes |
| Discomfort by the procedure | After the procedure ; 2-3hr |
| 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 |
| Lymph node features | During and after the procedure; 0-2hrs |
| Fentanyl/midazolam/lidocaine consumption | After the procedure ; 1-2 hrs |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |