Efficacy of cryobiopsy for peripheral pulmonary lesions
- Conditions
- Peripheral pulmonary lesion
- Registration Number
- JPRN-UMIN000049329
- Lead Sponsor
- ational Cancer Center Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 660
Not provided
1) Patients who have a past history of any local treatment (e.g., surgery, radiation therapy) for bronchial or pulmonary lesions ipsilateral to the target lesion. 2) Patients who have poorly controlled comorbidities (i.e., severe bronchial asthma, active pulmonary infection, low pulmonary function presenting with chronic respiratory failure, unstable angina, post-acute myocardial infarction, heart failure, and severe bleeding tendency). 3) Patients who have psychosis, psychiatric symptoms, or dementia that interfere with daily life. 4) Patients who take anticoagulant and/or antiplatelet medications and cannot discontinue them for the procedure. However, as for antiplatelet agents, only acetylsalicylic acid may be continued. 5) Other patients who are judged by the attending physician to be inappropriate as the subjects.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Diagnostic yield by histology
- Secondary Outcome Measures
Name Time Method 1) Sensitivity, specificity, and accuracy as to malignancy diagnosis 2) Diagnostic yield by specimen type 3) Cumulative diagnostic yield by number of tissue specimens 4) Incidence of (serious) adverse events 5) Procedure time 6) Success rate of genetic testing 7) Patient reported outcomes