The efficacy of sonographic and biological pleurodesis indicators of malignant pleural effusion (SIMPLE)

Not Applicable

Completed

Conditions: Malignant pleural effusion
Cancer
Secondary malignant neoplasm of pleura

Registration Number: ISRCTN16441661

Lead Sponsor: niversity of Oxford

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)

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 313

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ength of hospital stay (in days) during the initial hospitalisation

Secondary Outcome Measures

Name	Time	Method
1. Mortality rate is recorded at 12 months<br>2. Number of days in hospital post-randomisation with drain in situ<br>3. Patient reported dysponea/chest pain post-randomisation is measured through daily assessments for 7 days and then weekly for 4 weeks<br>4. Patient reported quality of life is measured using the EQ-5D-5L questionnaire at baseline, 1 and 3 months<br>5. Pleurodesis success is determined at 1 and 3 months<br>6. Use of healthcare resources and costs using utilisation logs is measured as discharge, 1 and 3 months