Randomized study of endobronchial ultrasound (EBUS)-guided transbronchial biopsy (TBB) with virtual bronchoscopic navigation (VBN) for the diagnosis of small peripheral pulmonary lesions: guide sheath (GS) method vs. non-guide sheath method (Non-GS)
Phase 3
- Conditions
- Benign or malignant pulmonary lesions
- Registration Number
- JPRN-UMIN000024305
- Lead Sponsor
- agoya Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 600
Inclusion Criteria
Not provided
Exclusion Criteria
1. Serious concomitant medical illness 2. Central pulmonary lesions 3. Lesion located within the inner third ellipse from the hilum on chest CT 4. Re-examination following prior failure in this trial 5. Case with pure ground glass nodule 6. Patients needing to undergo bronchoscopic procedures for non-target lesion in the same setting 7. Diffuse pulmonary lesions 8. Pregnancy 9. Bleeding tendency 10. Other clinical difficulties in this trial
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.Diagnostic yield of histology specimens
- Secondary Outcome Measures
Name Time Method 1.Overall diagnostic yield of the combination of culture, cytology, and histology specimens 2.Diagnostic yield: benign or malignant 3.Diagnostic yield according to lesion size: < 20 mm or > 20 mm 4.Diagnostic yield according to lesion location relative to the hilum: middle third ellipse or outer third ellipse 5.Diagnostic yield according to lesion location in the bronchopulmonary segment 6.Visibility with EBUS 7.Diagnostic yield according to the probe location relative to the target lesion 8.Diagnostic yield according to the presence of the air bronchus sign 9.Diagnostic yield according to lesion appearance on computed tomography (CT): solid or ground glass nodule 10.Level of bronchus reached 11.Time taken for examination procedure 12.Incidence of adverse effects