Phase II study of endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) and transesophageal bronchoscopic ultrasound-guided fine needle aspiration (TEBUS-FNA) using an EBUS bronchoscope in the mediastinal staging of non-small cell lung cancer
Phase 2
- Conditions
- ung cancer
- Registration Number
- JPRN-UMIN000002882
- Lead Sponsor
- agoya Medical Center
- Brief Summary
EBUS-TBNA was performed for 257 lymph nodes, and EUS-FNA for 176 lymph nodes. A total of 146 patients had a final diagnosis of non-small cell lung cancer. Thirty-three of them (23%) had N2 and/or N3 node metastases. The sensitivity of EBUS-TBNA, EUS-FNA and the combined approach per patient was 52%, 45% and 73%, respectively (EBUS-TBNA vs combined approach: p = 0.016 using McNemar test). The negative predictive value was 88%, 86% and 93%, respectively. Two cases (1%) of severe cough resulted from EBUS-TBNA.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 140
Inclusion Criteria
Not provided
Exclusion Criteria
1. Patients with recurrent lung cancer 2. Bleeding tendency 3. Pregnant woman 4. Other clinical difficulties in this study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Accuracy of EBUS-TBNA and/or TEBUS-FNA
- Secondary Outcome Measures
Name Time Method 1. Accuracy of non-invasive modalities (PET, CT) 2. Time of procedure 3. Frequency of adverse effects