A phase II study of using a thin bronchoscope (XBF-3B40Y1) for the diagnosis of peripheral pulmonary lesions - Utility of thin bronchoscope for the diagnosis of peripheral pulmonary lesions
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 170
Study Overview
Brief Summary
A total of 118 patients were included in this prospective study. Endobronchial lesions were visualized with the standard bronchoscope in 16 patients, and the other 102 patients underwent biopsies with the thin bronchoscope. Four patients were lost to follow-up. Thus, a total of 98 patients with peripheral pulmonary lesions (median size, 30.5 mm) were included in the final analysis. The mean bronchus level reached with the standard bronchoscope and the thin bronchoscope was 2.3 and 4.3 generations, respectively. Endobronchial abnormality was revealed with the thin bronchoscope in a further 14 patients. Diagnostic material was obtained in 50 of 68 patients (74%) with malignant disease and 18 of 30 patients (60%) with benign disease. There were no major complications.
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 20years-old to ot applicable (—)
- Sex
- All
Inclusion Criteria
- Not provided
Exclusion Criteria
- •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