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MesoTRAP: a feasibility study that includes a pilot clinical trial comparing video-assisted thoracoscopic partial pleurectomy decortication with indwelling pleural catheter in patients with trapped lung due to malignant pleural mesothelioma designed to address recruitment and randomisation uncertainties and sample size requirements for a phase III trial
  1. Claire Matthews1,
  2. Carol Freeman1,
  3. Linda D Sharples2,
  4. Julia Fox-Rushby3,
  5. Angela Tod4,
  6. Nicholas A Maskell5,
  7. John G Edwards6,
  8. Aman S Coonar7,
  9. Pasupathy Sivasothy8,
  10. Victoria Hughes1,
  11. Najib M Rahman9,
  12. David A Waller10 and
  13. Robert Campbell Rintoul1,11
  14. on behalf of the MesoTRAP investigators
    1. 1 Papworth Trials Unit Collaboration, Royal Papworth Hospital NHS Foundation Trust, Cambridge, UK
    2. 2 Department of Medical Statistics, London School of Hygiene & Tropical Medicine, London, UK
    3. 3 Department of Primary Care and Public Health Sciences, King's College London, London, UK
    4. 4 School of Nursing and Midwifery, University of Sheffield, Sheffield, UK
    5. 5 Academic Respiratory Unit, University of Bristol, Bristol, UK
    6. 6 Department of Thoracic Surgery, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, UK
    7. 7 Department of Thoracic Surgery, Royal Papworth Hospital NHS Foundation Trust, Cambridge, UK
    8. 8 Department of Medicine, Cambridge University Hospitals, Cambridge, UK
    9. 9 Nuffield Department of Medicine, University of Oxford, Oxford, UK
    10. 10 Department of Thoracic Surgery, St Bartholomew’s Hospital, London, UK
    11. 11 Department of Oncology, University of Cambridge, Cambridge, UK
    1. Correspondence to Robert Campbell Rintoul; robert.rintoul{at}nhs.net

    Abstract

    Introduction One of the most debilitating symptoms of malignant pleural mesothelioma (MPM) is dyspnoea caused by pleural effusion. MPM can be complicated by the presence of tumour on the visceral pleura preventing the lung from re-expanding, known as trapped lung (TL). There is currently no consensus on the best way to manage TL. One approach is insertion of an indwelling pleural catheter (IPC) under local anaesthesia. Another is video-assisted thoracoscopic partial pleurectomy/decortication (VAT-PD). Performed under general anaesthesia, VAT-PD permits surgical removal of the rind of tumour from the visceral pleura thereby allowing the lung to fully re-expand.

    Methods and analysis MesoTRAP is a feasibility study that includes a pilot multicentre, randomised controlled clinical trial comparing VAT-PD with IPC in patients with TL and pleural effusion due to MPM. The primary objective is to measure the SD of visual analogue scale scores for dyspnoea following randomisation and examine the patterns of change over time in each treatment group. Secondary objectives include documenting survival and adverse events, estimating the incidence and prevalence of TL in patients with MPM, examining completion of alternative forms of data capture for economic evaluation and determining the ability to randomise 38 patients in 18 months.

    Ethics and dissemination This study was approved by the East of England-Cambridge Central Research Ethics Committee and the Health Research Authority (reference number 16/EE/0370). We aim to publish the outputs of this work in international peer-reviewed journals compliant with an Open Access policy.

    Trial registration NCT03412357.

    • mesothelioma
    • pleural disease
    • thoracic surgery
    • asbestos induced lung disease

    This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: http://creativecommons.org/licenses/by/4.0

    https://doi.org/10.1136/bmjresp-2018-000368

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      Footnotes

      • Collaborators Mr Kelvin Lau (St Bartholomew's Hospital, London). Mr M Nidal Bittar (Victoria Hospital, Blackpool). Mr Antonio Martin-Ucar (University Hospitals, Coventry). Dr Jurgen Herre (Cambridge University Hospitals). Dr Paul Beckett (Royal Derby Hospital). Mr Alan Kirk (Golden Jubilee National Hospital, Scotland). Dr Kevin Blyth (Queen Elizabeth University Hospital, Glasgow). Mr Apostolos Nakas (Glenfield Hospital, Leicester). Dr Eleanor Mishra (Norfolk and Norwich University Hospitals). Dr Shahul Khan (Royal Stoke University Hospital). Dr Helen Roberts (Nottingham University Hospitals NHS Trust). Mr Dionisios Stavroulis (John Radcliffe Hospital, Oxford). Dr Louise Brown (The Pennine Acute Hospitals NHS Trust). Dr Mohammed Munawar (Lancashire Teaching Hospitals). Dr Matthew Evison (University Hospital of South Manchester).

      • Contributors RCR conceived the study and designed it in conjunction with CF, LDS, JF-R, AT, NAM, NMR, ASC, JGE and DAW. All authors contributed to revisions and approved the final manuscript.

      • Funding This project was funded by the National Institute for Health Research Research for Patient Benefit PB-PG-1014-35050.

      • Disclaimer The views expressed are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health.

      • Competing interests None declared.

      • Patient consent Not required.

      • Ethics approval Study approval was conferred by the Cambridge Central Research Ethics Committee Ref: 16/EE/0370.

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