Randomized study of endobronchial ultrasound-guided transbronchial biopsy with virtual bronchoscopic navigation (EBUS-TBB-VBN) using 3.0-mm thin bronchoscope vs. 4.0-mm bronchoscope with guide sheath (GS) for diagnosis of small peripheral pulmonary lesio
Phase 3
Completed
- Conditions
- Benign or malignant pulmonary lesions
- Registration Number
- JPRN-UMIN000003177
- Lead Sponsor
- agoya Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 300
Inclusion Criteria
Not provided
Exclusion Criteria
1. Case with serious concomitant medical illness 2. Central pulmonary lesions 3. Diffuse pulmonary lesions 4. Re-examination due to prior failure in this trial 5. Case with pure ground glass opacity 6. Patients needing to undergo other bronchoscopic procedures (e.g. TBNA, BAL) 7. Bleeding tendency 8. Pregnant woman 9. Other clinical difficulties in this trial
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Diagnostic yield on histology specimens
- Secondary Outcome Measures
Name Time Method 1. Overall diagnostic yield on the combination of culture, cytology and histology specimens 2. Diagnostic yield according to benign or malignant 3. Diagnostic yield according to lesion 20 mm> or 20 mm< in size 4. Diagnostic yield according to location 5. Visibility on EBUS 6. Diagnostic yield according to location of probe in relation to target lesion 7. Level of bronchus reached 8. Level of bronchus imaged by VBN system 9. Direct visibility of lesions with bronchoscope 10. Time of procedure 11. Frequency of adverse effects