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Clinical Trials/ISRCTN16441661
ISRCTN16441661
Completed
N/A

The efficacy of Sonographic and bIological pleurodesis indicators of Malignant PLeural Effusion (SIMPLE) -­ a randomised trial

niversity of Oxford0 sites313 target enrollmentFebruary 10, 2016

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)

Registry
who.int
Start Date
February 10, 2016
End Date
December 31, 2019
Last Updated
last year
Study Type
Interventional
Sex
All

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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