Bronchoscopic lung marking to resect small pulmonary lesions: an open-label, uncontrolled, single-arm study
Not Applicable
- Conditions
- A pulmonary lesion suspected or diagnosed as malignancy
- Registration Number
- JPRN-UMIN000022991
- Lead Sponsor
- Ministry of health, labor, and welfare
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 160
Inclusion Criteria
Not provided
Exclusion Criteria
1) Allergic to indigocarmine 2) Pregnant 3) Complications that do not allow for bronchoscopy or the marking procedure 4) Other cases a medical doctor in charge judged as inappropriate for registeration
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Successful resection of pulmonary lesions with sufficient resection margins* *Resection margins larger than the tumor diameter or 2 cm
- Secondary Outcome Measures
Name Time Method 1) Efficacy of markings 2) Efficacy of marking-assisted surgery 3) Safety (observed until post-operative day 30)