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

ISRCTN	ISRCTN16441661
DOI	https://doi.org/10.1186/ISRCTN16441661
Protocol serial number	CPMS 20343
Sponsor	University of Oxford
Funder	Cancer Research UK

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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-trial-looking-at-using-ultrasound-and-biomarkers-in-treatment-for-pleural-effusion-simple

Contact information

Prof Ioannis Psallidas
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

Primary study design	Interventional
Study design	Multi-centre randomized controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant 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(s)	Length of hospital stay (in days) during the initial hospitalisation
Key secondary outcome measure(s)	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
Completion date	31/12/2019

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	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

United Kingdom
England

Study participating centre

University of Oxford

Respiratory Medicine Unit
NDM Research Building
Nuffield Department of Medicine
Old Road Campus
Oxford
OX3 7FZ
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		08/10/2021	12/10/2021	Yes	No
Protocol article	protocol	20/11/2017		Yes	No
HRA research summary			28/06/2023	No	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
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.