malignant pleural effusion
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Malignant pleural effusion confirmed by histopathology or cytology. 2. Symptomatic with malignant pleural effusion and needs intervention. 3. Relief of symptoms is expected with drainage of pleural effusion. 4. Life expectancy of 30 days or more. 5. ECOG PS is expected to be 0-2 after darainage of pleural effusion. 6. 20 years of age or older. 7. Written informed consent from patient is gained.
Exclusion criteria
Exclusion criteria: 1. Hypersensitivity to talc. 2. Hypersensitivity to lidocaine hydrochrolide. 3. Severe infection. 4. Severe hypoxemia despite oxgen therapy. 5. Uncontrolled angina or heart failure. 6. Myocardical infarction within 30 days of consent. 7. Severe bleeding diathesis. INR > 2.0 or platelet <60000/mm3. 8. Severe pleural adhesion. 9. Indication for bilateral pleurodesis. 10. History of pleurodeis of affected side. 11. Preganant or during lactation. Patient who hopes to bear child, or who can not keep contraceptive maneuver. 12. Inappropriate to enter this trial judged by the physician in charge
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pleural effusion control rate 30 days after talc poudrage. | — |
Secondary
| Measure | Time frame |
|---|---|
| Pain, pyrexia, oxygen saturation, and flow rate of oxygen after talc poudrage. Adverse effect. Time to reccurence of pleural effusion. | — |
Countries
Japan
Contacts
Nishichita General Hospital Department of Repiratory Medicine