Talc pleurodesis for malignant pleural effusions
- Conditions
- Malignant Pleural Effusions
- Registration Number
- JPRN-jRCT2091220029
- Lead Sponsor
- Hideo Saka, M.D., National Hospital Organization, Nagoya Medical Center
- Brief Summary
Effective and safe
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pleural effusion control rate on 30th day of pleurodesis
- Secondary Outcome Measures
Name Time Method 1. Degree of dyspnea on 30th day of pleurodesis<br> 2. Degree of pain on 30th day of pleurodesis