Malignant pleural effusion
Conditions
Interventions
Instillation of OK-432 0.2KE/kg (max. 10KE) distilled in 50 mL of saline into thoracic cavity. Add another 50 mL of saline. After 2 hours, open drainage tube closure, use negative pressure pump. When
Sponsors
West Japan Oncology Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically or cytologically proven malignant pleural effusion (original tumor should be lung cancer or gastrointestinal cancer) 2) To control dyspnea due to malignant pleural effusion and the procedure is the priority 3) To meet all the following criteria: malignant pleural effusion drainage is already done and, a) The lung re-expanded by the drainage, b) Symptom like dyspnea et al was improved by the drainage, c) Eastern Cooperative Oncology Group (ECOG) performance status is 0, 1, or 2, d) SpO2 >= 90% in fresh air 4) Life expectancy <= 30 days after pleurodesis 5) Written informed consent from the patient
Exclusion criteria
Exclusion criteria: 1) Hypersensitivity to talc or OK-432 2) Hypersensitivity to penicillin derivatives 3) Serious infection 4) Severe pulmonary emphysema or fibrosis 5) Treatment of heart failure 6) A history of myocardial infarction within 30 days of concent 7) Severe coagulopathy 8) Severe pleural adhesion 9) Requirement of bilateral simultaneous pleurodesis 10) A history of surgical procedure like lobectomy or total lung resection, in the affected lung 11) A history of pleurodesis on the affected side or contralateral side 12) Massive ascites 13) Systemic glucocorticosteroid (oral or intravenous), some reports revealed the possible negative effects on pleurodesis by the corticosteroids 14) Pregnant women, breast feeding women, potential pregnant women, women not intention to avoid pregnancy 15) Pshychiatric diorders 16) Not fit for this trial judged by the doctor in charge
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pleural effusion relapse-free rate at Day 30 after pleurosesis | — |
Secondary
| Measure | Time frame |
|---|---|
| Pleural effusion relapse-free survival time, pleural effusion relapse-free survival rate in every 3 month, Quality of life, Side effects | — |
Countries
Japan
Contacts
Public ContactShinichiro Nakamura
West Japan Oncology Group WJOG datacenter
Outcome results
None listed