A study of safety and efficacy of bronchoscope biopsy with a Cryoprobe.
Not Applicable
Recruiting
- Conditions
- ung tumor, Diffuse interstitial lung disease
- Registration Number
- JPRN-UMIN000034546
- Lead Sponsor
- International University of Health and Welfare, Mita hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 150
Inclusion Criteria
Not provided
Exclusion Criteria
1) Serious hypersensitivity to lidocaine, midazolam, pethidine hydrochloride or other drugs. 2) Using antiplatelet or anticoagulation therapy (an appropriate discontinuation period is necessary). 3) Current or previous history of continuing bloody sputum (>1 tea spoon) within one month. 4) Evidence of tumor invading the hilum of lung, a heart, and major blood vessels on imaging. 5) Severe complications (e.g., uncontrollable peptic ulcer, gastrointestinal bleeding, angina pectoris, cardiovascular disease, or infection) 6) Severe infections 7) Pregnancy, breast feeding and suspected pregnancy. 8) Inappropriate for this study judged by the attending doctor
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Ratio of the trachea and the bronchus severe bleeding to need for additional intervention, e.g. instillation of ice-cold saline or a diluted vasoconstrictive drug, balloon tamponade, argon plasma coagulation, conversion to rigid bronchoscopy or mechanical ventilation.
- Secondary Outcome Measures
Name Time Method Ratio of the trachea and the bronchus mild or moderate bleeding Adverse events except the trachea and the bronchus bleeding Definitive diagnosis ratio Size of the specimen (e.g., longer axis, minor axis, area) on pathologic review. Exploratory examination about relations of the pneumothorax and distance between Cryoprobe and the pleura.