Malignant Pleural Effusions
Conditions
Interventions
Intervention type:DRUG
Name of intervention:talc
Dose form / Japanese Medical Device Nomenclature:INJECTION
Route of administration / Site of application:INTRAPLEURAL
Dose per administration:4
grams
D
Sponsors
Hideo Saka, M.D., National Hospital Organization, Nagoya Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Cytologically or histologically proven malignant pleural effusions 2) Symptomatic with malignant pleural effusion and needs intervention 3) Re-expansion of the lung by chest tube drainage 4) Improved symptoms by drainage of pleural effusion 5) Life expectancy of 30 days or more after pleurodesis 6) Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2 after malignant pleural effusion drainage 7) 20 years of age or more, and less than 75 years. 8) Written informed consent from the patient
Exclusion criteria
Exclusion criteria: 1) Hypersensitive to talc 2) Hypersensitive to lidocaine chloride 3) Severe infection 4) Severe pulmonary emphysema or fibrosis 5) Treatment of active heart failure 6) History of myocardial infarction within 30 days of entry 7) Severe coagulopathy 8) SpO2 less than 90% after drainage 9) Severe pleural adhesion 10) Indication for bilateral pleurodesis 11) History of thoracic surgery like lung resection or pleuro-pulmonary resection on the affected side 12) History of pleurodesis on the affected side 13) Use of systemic corticosteroid and non-steroidal anti-inflammatory agents 14) Pregnant or milk-feeding female, patient who hopes to bear child, or who could not keep contraceptive maneuver 15) Participant of other trial drug study within 6 monthes 16) Inappropriate to enter this trial judged by the physician in charge
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pleural effusion control rate on 30th day of pleurodesis | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Degree of dyspnea on 30th day of pleurodesis 2. Degree of pain on 30th day of pleurodesis | — |
Countries
Japan
Contacts
Public ContactHideo Saka, M.D.
National Hospital Organization, Nagoya Medical Center
Outcome results
None listed