Skip to content

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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN16441661
Enrollment
344
Registered
2016-02-10
Start date
2015-12-14
Completion date
Unknown
Last updated
2024-06-18

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

Conditions

Malignant pleural effusion Cancer Secondary malignant neoplasm of pleura

Interventions

Participants are randomly allocated to one of two groups: Intervention group: Participants receive thoracic ultrasound imaging before and post talc administration. Control group: Participants receive

Sponsors

University of Oxford
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion 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

Exclusion criteria: 1. Aged under 18 years 2. Poor prognosis (pleurodesis not offered in normal practice) 3. Irreversible contra-indication to drain insertion

Design outcomes

Primary

MeasureTime frame
Length of hospital stay (in days) during the initial hospitalisation

Secondary

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

Countries

England, United Kingdom

Contacts

Public ContactIoannis Psallidas

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 21, 2026