ISRCTN16441661
Completed
N/A
The efficacy of Sonographic and bIological pleurodesis indicators of Malignant PLeural Effusion (SIMPLE) - a randomised trial
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Malignant pleural effusion
- Sponsor
- niversity of Oxford
- Enrollment
- 313
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
2017 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/29225889 protocol 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34634246/ (added 12/10/2021)
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Clinically confident diagnosis of MPE requiring pleurodesis defined as any of the following (more than one can be included):
- •1\.1\. Histocytologically proven MPE
- •1\.2\. Thoracic CT evidence of pleural malignancy
- •1\.3\. Otherwise unexplained exudative effusion in the context of clinically proven cancer elsewhere
- •2\. Written informed consent
Exclusion Criteria
- •1\. Aged under 18 years
- •2\. Poor prognosis (pleurodesis not offered in normal practice)
- •3\. Irreversible contra\-indication to drain insertion
Outcomes
Primary Outcomes
Not specified
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