Efficacy of sonographic and biological pleurodesis indicators of malignant pleural effusion (SIMPLE): protocol of a randomised controlled trial

Our plain-English summary of Efficacy of sonographic and biological pleurodesis indicators of malignant pleural effusion (SIMPLE): protocol of a randomised controlled trial, by I. Psallidas, H.E.G. Piotrowska, A. Yousuf, et al (BMJ Open Respiratory Research, 2017).

The study

• Authors: I. Psallidas, H.E.G. Piotrowska, A. Yousuf, N.I. Kanellakis, G. Kagithala, S. Mohammed, L. Clifton, J.P. Corcoran, N. Russell, M. Dobson, R.F. Miller, N.M. Rahman
• Journal: BMJ Open Respiratory Research
• Published: 2017;4(1):e000225
• Cited by: 9 articles, as counted by NIH iCite
• Read it: PubMed · Publisher · Free full text

Abstract

Introduction: Malignant pleural effusion (MPE) is common and currently in UK there are an estimated 50 000 new cases of MPE per year. Talc pleurodesis remains one of the most popular methods for fluid control. The value of thoracic ultrasound (TUS) imaging, before and after pleurodesis, in improving the quality and efficacy of care for patients with MPE remains unknown. Additionally, biomarkers of successful pleurodesis including measurement of pleural fluid proteins have not been validated in prospective studies.The SIMPLE trial is an appropriately powered, multicentre, randomised controlled trial designed to assess 'by the patient bedside' use of TUS imaging and pleural fluid analysis in improving management of MPE.

Methods And Analysis: 262 participants with a confirmed MPE requiring intervention will be recruited from hospitals in UK and The Netherlands. Participants will be randomised (1:1) to undergo either chest drain insertion followed by instillation of sterile talc, or medical thoracoscopy and simultaneous poudrage. The allocated procedure will be done while the patient is hospitalised, and within 3 days of randomisation. Following hospital discharge, participants will be followed up at 1, 3 and 12 months. The primary outcome measure is the length of hospital stay during initial hospitalisation.

Ethics And Dissemination: The trial has received ethical approval from the South Central-Oxford C Research Ethics Committee (Reference number 15/SC/0600). The Trial Steering Committee includes an independent chair and members, and a patient representative. The trial results will be published in a peer-reviewed journal and presented at international conferences.

Trial Registration Number: ISRCTN: 16441661.

In plain English

This article was the published protocol for a trial called SIMPLE; it reported no results. The authors planned a multicentre, unblinded randomised controlled trial of at least 262 adults with a confirmed malignant pleural effusion (fluid around the lung caused by cancer) who needed talc pleurodesis, a treatment meant to seal the space around the lung so the fluid does not return. Talc can be given as a slurry through a chest drain, or blown in during thoracoscopy, a camera procedure. Participants from UK and Netherlands hospitals were to be randomly assigned to standard care or ultrasound-guided care. In standard care, chest X-rays and fluid output would decide when slurry talc was given, and guideline criteria would decide drain removal after either method. In ultrasound-guided care, bedside ultrasound of remaining fluid would decide when slurry talc was given, and a lung-sliding score at nine chest sites would guide drain removal after either method. The main question was whether ultrasound-guided care reduced days in hospital during the first admission. The article did not mention asbestos or mesothelioma.

We wrote this plain-English summary from the full article with the help of AI, and a second AI model checked each sentence against the article. It is not the authors' wording; the abstract and the article are their own account.

What the study did and found

• Design: Protocol (plan) for a multicentre, unblinded randomised controlled trial; no results reported
• Who was studied: A planned minimum of 262 participants aged 18 or over with a confirmed malignant pleural effusion requiring pleurodesis, to be recruited from hospitals in the UK and the Netherlands
• Exposure: No asbestos exposure was studied. The trial compared thoracic ultrasound-guided care with standard care (chest X-ray and fluid output). Talc was given either as slurry through a chest drain or as poudrage during thoracoscopy. For slurry, ultrasound of residual fluid timed talc in the ultrasound arm. For poudrage, ultrasound was done only after pleurodesis. A lung-sliding score guided drain removal in the ultrasound arm. The main outcome was days in hospital during the initial hospitalisation.

Topics

Medical terms in this study, explained in our Lexicon: Pleurodesis, Pleural Effusion, Talc Pleurodesis, Ultrasound, Biomarker, Talc, Medical Thoracoscopy.

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