Lung tumor, Diffuse interstitial lung disease
Conditions
Interventions
Bronchoscope biopsy with a Cryoprobe
Sponsors
International University of Health and Welfare, Mita hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) In chest CT, the following diseases have been already diagnosed or is suspected; the patient who needs transbronchial biopsy using bronchoscope. 1: Primary lung cancer 2: Metastatic lung cancer 3: Diffuse interstitial lung disease 2) Age 20 to 80 years 3) ECOG Performance status of 0, 1, or 2 4) Adequate organ function, as - Absolute neutrophil count > or = 1,500/mm3 - Hemoglobin > or = 9.0g/dL - Platelet count > or = 10x10,000/mm3 - AST and ALT < or = 100 IU/L - Total bilirubin level < or = 1.5mg/dL - Serum creatinine level < or = 1.5mg/dL - Prothrombin time-International normalized ratio < or = 1.5 - Oxygen saturation (Room air) > or = 90% - Forced expiratory volume in 1 second > or = 1.0L 5) Written informed consent
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Japan
Contacts
Public ContactSeisuke Nagase
International University of Health and Welfare, Mita hospital Respiratory Disease Center
Outcome results
None listed