The efficacy of sonographic and biological pleurodesis indicators of malignant pleural effusion (SIMPLE)
| ISRCTN | ISRCTN16441661 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16441661 |
| Secondary identifying numbers | CPMS 20343 |
- Submission date
- 10/02/2016
- Registration date
- 10/02/2016
- Last edited
- 04/06/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English summary of protocol
Contact information
Public
Centre for Respiratory Medicine
University College London
Rayne Building
5 University Street
London
WC1E 6JF
United Kingdom
 ORCID ID |
0000-0001-7284-0111 |
|---|
Study information
| Study design | Multi-centre randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | The efficacy of Sonographic and bIological pleurodesis indicators of Malignant PLeural Effusion (SIMPLE) - a randomised trial |
| Study acronym | SIMPLE |
| Study objectives | The aim of this trial is to: 1. Establish if a novel radiological investigation (thoracic ultrasound) can improve quality and efficacy of care for MPE patients undergoing talc pleurodesis 2. Establish a biobank of prospectively collected biological samples and radiology in patients undergoing talc pleurodesis, linked to robust outcome data, to investigate factors associated with pleurodesis “success” and redefine the current understanding in a patient centred model |
| Ethics approval(s) | 12/11/2015, ref: 15/SC/0600 |
| Health condition(s) or problem(s) studied | Malignant pleural effusion |
| Intervention | 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 talc pleurodesis with no thoracic ultrasound imaging. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Length of hospital stay (in days) during the initial hospitalisation |
| Secondary outcome measures | 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 |
| Overall study start date | 14/12/2015 |
| Completion date | 31/12/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | Planned Sample Size: 344; UK Sample Size: 344 |
| Total final enrolment | 313 |
| Key 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 |
| Key exclusion criteria | 1. Aged under 18 years 2. Poor prognosis (pleurodesis not offered in normal practice) 3. Irreversible contra-indication to drain insertion |
| Date of first enrolment | 14/12/2015 |
| Date of final enrolment | 30/09/2019 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
NDM Research Building
Nuffield Department of Medicine
Old Road Campus
Oxford
OX3 7FZ
United Kingdom
Sponsor information
Hospital/treatment centre
Research Services
Clinical Trials and Research Governance
Headley Way
Headington
Oxford
OX3 9DU
England
United Kingdom
"ROR" |
https://ror.org/052gg0110 |
|---|
Funders
Funder type
Charity
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- CR_UK, Cancer Research UK - London, CRUK
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 30/04/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 20/11/2017 | Yes | No | |
| Results article | 08/10/2021 | 12/10/2021 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No | ||
| Plain English results | 04/06/2024 | No | Yes |
Editorial Notes
04/06/2024: Cancer Research UK plain English results link added.
12/10/2021: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
29/04/2019: The public contact details have been changed.
02/04/2019: The condition has been changed from "Topic: Cancer, Respiratory disorders; Subtopic: Lung Cancer, Respiratory (all Subtopics); Disease: Lung (small cell), Lung (non-small cell), Lymphoma (Hodgkin's), Lymphoma (non-Hodgkin's), Mesothelioma, Respiratory, Lymphoma (Non Hodgkins - aggressive), Lymphoma (Non Hodgkins - indolent), Lymphoma (other)" to "Malignant pleural effusion" following a request from the NIHR.
14/01/2019: The Planned Sample Size has been updated from 262 to 344.
10/01/2019: The following changes have been made:
1. The recruitment end date has been updated from 31/12/2018 to 30/09/2019.
2. The overall trial end date has been updated from 31/12/2018 to 31/12/2019.
3. The intention to publish date has been updated from 31/12/2019 to 30/04/2020.
4. The total target enrolment has been updated from 262 to 344.
15/02/2018: Publication reference added.
09/06/2016: Link to Cancer Help UK lay summary added.
