A prospective study on the safety and efficacy of cryobiopsy using an ultrathin cryoprobe and a therapeutic bronchoscope to assess peripheral pulmonary lesions
Phase 3
Recruiting
- Conditions
- Peripheral pulmonary lesions under suspicion of malignancy
- Registration Number
- JPRN-UMIN000050604
- Lead Sponsor
- ational Hospital Organization Nagoya Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
Not provided
Exclusion Criteria
1. Any serious, concomitant medical condition 2. Lesion located within one-third of the hilar ellipse as revealed by chest computed tomography 3. The need for a bronchoscopic procedure exploring a non-target lesion in the same setting 4. A lesion near a large vessel 5. A distance < 10 mm between the visceral pleura and the central margin of the lesion 6. Prior enrolment in the trial 7. Patients for whom a therapeutic bronchoscope and a 1.1-mm cryoprobe were not used 8. Pregnancy 9. The inability to temporarily interrupt anticoagulant/antiplatelet agents 10. A bleeding tendency
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Safety (bleeding-related)
- Secondary Outcome Measures
Name Time Method 1. Safety (other than bleeding-related) 2. Histological diagnostic yield 3. Procedure duration 4. Specimen size 5. Sampling success in terms of the freezing time 6. Biomarker test success rate