Phase II study of endobronchial ultrasound (EBUS)-guided transbronchial biopsy using thin bronchoscope (XBF-3B260Y1) with miniature probe (XUM-S20-17R) for diagnosis of peripheral pulmonary lesions
- Conditions
- Benign or malignant pulmonary lesions
- Registration Number
- JPRN-UMIN000000509
- Lead Sponsor
- agoya Medical Center
- Brief Summary
A total of 86 patients with suspected peripheral lesions were included in this prospective study. Twelve patients with endobronchial lesions within the segmental bronchi and 3 patients who did not return to follow-up were excluded from this analysis. Thus, a total of 71 patients with peripheral pulmonary lesions (mean size, 31.2 +- 12.7 mm) were included in the final analysis. The mean bronchus level reached with the thin bronchoscope was 4.6 generations. Diagnostic histologic specimens were obtained in 49 of 71 patients (69%: 80% for malignant lesions and 52% for benign lesions). There were no significant complications.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 140
Not provided
1. Serious concomitant medical illness 2. Obvious central pulmonary lesion 3. Diffuse pulmonary lesions 4. Re-examination due to prior failure in this trial 5. Obvious bleeding tendency 6. Pregnancy 7. Other clinical difficulties in this study
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Diagnostic yield
- Secondary Outcome Measures
Name Time Method 1. Frequency of adverse effects 2. Level of bronchus reached 3. Visibility on EBUS 4. Direct visibility of lesions with bronchoscope 5. Optimal number of biopsies