A prospective study on the safety and efficacy of additional cryobiopsy using an ultrathin cryoprobe to ROSE(;rapid on-site cytologic evaluation) negative of forceps biopsy
Not Applicable
- Conditions
- Peripheral pulmonary lesions which is suspected malignancy
- Registration Number
- JPRN-UMIN000052642
- Lead Sponsor
- HO Okayama Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
Not provided
Exclusion Criteria
1. Any serious medical condition to procedure bronchoscopy 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. Pregnance 8. The inability to temporarily interrupt anticoagulant/antiplatelet agents 9. A bleeding tendency
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety
- Secondary Outcome Measures
Name Time Method Pathological diagnosis yield Procedure time Sample size of forceps biopsy and cryobiopsy Freezing time and specimen success rate Biomarker test success rate Result of rapid on-site cytologic evaluation