SIMPLE
Research type
Research Study
Full title
The Efficacy of Sonographic and Biological Pleurodesis Indicators of Malignant Pleural Effusion (SIMPLE) - a randomised trial
IRAS ID
187954
Contact name
Heather House
Contact email
Sponsor organisation
University of Oxford
Duration of Study in the UK
3 years, 2 months, 31 days
Research summary
Patients who suffer with cancer often develop fluid around the lungs known as a malignant pleural effusion (MPE). Clinicians commonly treat MPEs by either performing a chest drain with talc slurry or thoracoscopy with talc poudrage requiring patients to stay in hospital for a number of days. Both procedures drain the pleural fluid and then apply talc (known as talc pleurodesis) to prevent fluid reoccurrence. The drain is left in the patient throughout their hospital stay as it is believed that talc increases pleural fluid production in the first 24-72 hours post application. However, there is currently no reliable data to inform the clinician of the optimal timing of talc administration as well as drain withdrawal post talc pleurodesis.
In addition, there is a lack of data assessing pleural fluid protein expression profile to predict pleurodesis success. Identifying the pleural fluid biomarkers of pleurodesis success will enable clinicians to stratify patients' management to either pleurodesis or alternative treatments improving the efficacy and quality of care of patients with MPE.
The SIMPLE trial is a multi-centre randomised controlled trial to evaluate whether the use of thoracic ultrasound, before and during the first 24-72 hours post talc administration, in patients with MPE accurately identifies pleural adherence early in treatment, permitting shorter hospital stay without reducing pleurodesis success. SIMPLE will also assess the pleural fluid protein profile, before and after talc administration, to determine whether there are factors that can predict pleurodesis success.REC name
South Central - Oxford C Research Ethics Committee
REC reference
15/SC/0600
Date of REC Opinion
10 Nov 2015
REC opinion
Favourable Opinion