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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON44184

Enrollment

Registered

2018-01-29

Start date

2018-03-06

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

fluid around the lung caused by cancer malignant pleural effusion (MPE)

Interventions

Patients will be randomised to standard care or TUS guided care. These are specified in detail in the appropriate trial specific instructions (TSI). * * Standard care: Patients will have either thora

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: 1. Age

Design outcomes

Secondary

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

Measure

Time frame

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

—

Primary

Measure	Time frame
Length of hospital stay (in days) during the initial hospitalisation. (from the time of randomisation until declared fit for discharge from hospital)	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)