Non Small Cell Lung Cancer Clinical Trial
Official title:
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.
Verified date | June 2011 |
Source | National Cancer Center, Korea |
Contact | n/a |
Is FDA regulated | No |
Health authority | Korea: Institutional Review Board |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 162 |
Est. completion date | February 2012 |
Est. primary completion date | February 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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) |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Diagnostic
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | National Cancer Center (NCC) Korea | Goyang | Gyeonggi-do |
Lead Sponsor | Collaborator |
---|---|
National Cancer Center, Korea |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Diagnostic accuracy | When the confimative disgnosis is available in all subjects (after surgery) ; 8-12 months | No | |
Secondary | Procedure time | During and just after the procedure ; 5-60 minutes | No | |
Secondary | Cardiovascular measurement (change of blood pressure, changes of heart rate, number of patients with arrhythmia) | During the procedure; 0-60 minutes | Yes | |
Secondary | Degree of desaturation | During the procedure; 0-60minutes | Yes | |
Secondary | Discomfort by the procedure | After the procedure ; 2-3hr | Yes | |
Secondary | 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 | Yes | |
Secondary | Lymph node features | During and after the procedure; 0-2hrs | No | |
Secondary | Fentanyl/midazolam/lidocaine consumption | After the procedure ; 1-2 hrs | Yes |
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