The efficacy of Sonographic and biological pleurodesis Indicators of Malignant Pleural Effusion (SIMPLE) - a randomised trial

Completed

• Conditions: 10027656; 10035597; malignant pleural effusion (MPE); fluid around the lung caused by cancer

• Registration Number: NL-OMON44184
• Lead Sponsor: Oxford Respiratory Trials Unit, University of Oxford

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 40

Inclusion Criteria

1. Clinically confident diagnosis of MPE requiring pleurodesis
2. written informed consent

Exclusion Criteria

1. Age <18 yrs
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
<p>Length of hospital stay (in days) during the initial hospitalisation. (from the<br /><br>time of randomisation until declared fit for discharge from hospital)</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1. Pleurodesis success at 1 and 3 months post randomisation (radiological and<br /><br>clinical evaluation to assess success at 1 and 3 months (need for further<br /><br>pleural interventions))<br /><br><br /><br>2. Number of days in hospital post randomisation with drain in situ.(from<br /><br>randomisation till drain removal)<br /><br><br /><br>3. EQ-5D-5L questionnaire (at presentation, 1 and 3 months post randomisation)<br /><br><br /><br>4. VAS assessment (at baseline and post pleurodesis (Daily for 7 days and then<br /><br>weekly for 4 weeks))<br /><br><br /><br>5. Healthcare utilisation logs (at discharge, 1 and 3 months post randomisation)<br /><br><br /><br>6. Mortality (at 12 months post randomisation)<br /><br><br /><br>7. Pleurodesis failure at 1 and 3 months post randomisation (radiological and<br /><br>clinical evaluations to assess success at 1 and 3 months (need for further<br /><br>pleural interventions))</p><br>