You are here

  • Home
  • Archive
  • Volume 4, Issue 1
  • Efficacy of sonographic and biological pleurodesis indicators of malignant pleural effusion (SIMPLE): protocol of a randomised controlled trial

Article Text

Article menu

Download PDFPDF

XML
Pleural Disease
Efficacy of sonographic and biological pleurodesis indicators of malignant pleural effusion (SIMPLE): protocol of a randomised controlled trial
  1. Ioannis Psallidas1,2,3,4,
  2. Hania E G Piotrowska3,
  3. Ahmed Yousuf1,3,
  4. Nikolaos I Kanellakis1,2,3,4,
  5. Gayathri Kagithala3,
  6. Seid Mohammed5,
  7. Lei Clifton5,
  8. John P Corcoran1,3,
  9. Nicky Russell3,
  10. Melissa Dobson3,
  11. Robert F Miller6,7 and
  12. Najib M Rahman1,2,3,4
  1. 1Oxford Centre for Respiratory Medicine, Churchill Hospital, Oxford University Hospitals NHS Foundation Trust, Oxford, UK
  2. 2Nuffield Department of Medicine, Laboratory of Pleural and Lung Cancer Translational Research, University of Oxford, Oxford, UK
  3. 3Oxford Respiratory Trials Unit, Nuffield Department of Medicine, University of Oxford, Oxford, UK
  4. 4National Institute for Health Research Oxford Biomedical Research Centre, University of Oxford, Oxford, UK
  5. 5Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, Centre for Statistics in Medicine, University of Oxford, Oxford, UK
  6. 6Institute of Global Health, University College London, London, UK
  7. 7Faculty of Infectious and Tropical Diseases, London School of Hygiene and Tropical Medicine, London, UK
  1. Correspondence to Dr Ioannis Psallidas; ioannis.psallidas{at}ndm.ox.ac.uk

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.

  • pleural disease
  • mesothelioma

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

https://doi.org/10.1136/bmjresp-2017-000225

Statistics from Altmetric.com

    Request Permissions

    If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.

    View Full Text

    Footnotes

    • Contributors IP and NMR conceived the initial trial concept. All authors (IP, HEGP, AY, NIK, GK, SM, LC, JPC, NR, MD, RFM, NMR) contributed to the development of the trial design and protocol. NMR, SM and LC carried out the sample size calculations. SM, LC, IP and NMR wrote the statistical analysis plan. All authors have read and approved this manuscript.

    • Funding IP is the recipient of a REPSIRE2 European Respiratory Society Fellowship (RESPIRE2-2015-7160). NMR is funded by the National Institute Health Research (NIHR) Oxford Biomedical Research Centre. SIMPLE study is funded by the Marie Curie Institute (C49481/A17178).

    • Competing interests None declared.

    • Ethics approval South Central-Oxford C Research Ethics Committee (Reference number 15/SC/0600).

    • Provenance and peer review Not commissioned; externally peer reviewed.