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

Our plain-English summary of 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, by C. Matthews, C. Freeman, L.D. Sharples, et al (BMJ Open Respiratory Research, 2019).

The study

• Authors: C. Matthews, C. Freeman, L.D. Sharples, J. Fox-Rushby, A. Tod, N.A. Maskell, J.G. Edwards, A.S. Coonar, P. Sivasothy, V. Hughes, N.M. Rahman, D.A. Waller, R.C. Rintoul
• Journal: BMJ Open Respiratory Research
• Published: 2019;6(1):e000368
• Cited by: 19 articles, as counted by NIH iCite
• Read it: PubMed · Publisher · Free full text

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.

In plain English

This article is a study protocol. It describes a planned study, MesoTRAP, and reports no results. MesoTRAP is a UK feasibility study that includes a small pilot randomised trial. It is for patients with malignant pleural mesothelioma who have fluid around the lung (pleural effusion) and whose lung cannot fully re-expand because tumour covers it, which is called 'trapped lung'. Patients were to be assigned by chance to one of two treatments. One was an indwelling pleural catheter, a soft tube placed under local anaesthesia that lets fluid be drained at home. The other was video-assisted thoracoscopic partial pleurectomy/decortication, surgery under general anaesthesia that removes tumour from the lung surface. The main aim was to measure how much patients' breathlessness scores varied after treatment, to help plan the size of a later, larger trial. Other aims included recording survival and serious adverse events, estimating how common trapped lung is, and testing whether 38 patients could be randomised in 18 months. Side studies were planned to follow patients who did not join the trial and to interview 15 patients. The study did not examine asbestos exposure.

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: Study protocol for a feasibility study that includes a pilot multicentre, open-label randomised controlled clinical trial, plus planned observational and qualitative substudies and a health economic feasibility study. No results are reported.
• Who was studied: Planned: adults (18 or older) with proven malignant pleural mesothelioma, a pleural effusion and clinically significant trapped lung, at mesothelioma surgical centres across the UK and their linked referral hospitals. The target was 38 randomised patients within 18 months.
• Exposure: The study compares two treatments: indwelling pleural catheter (IPC) and video-assisted thoracoscopic partial pleurectomy/decortication (VAT-PD). Asbestos exposure is not studied.
• The authors' conclusion: The article reports no findings. The authors state that if the pilot trial randomises 38 patients in 18 months and shows no evidence of harm from either intervention, they plan to develop it into a full phase III trial.
• Limitations the authors state:
  • The authors note that larger pilot sample sizes have been recommended, but say a much larger study was not feasible within a reasonable time frame, so they chose 38 patients.

Topics

The National Library of Medicine indexes this study under subjects our site covers: Lung cancer, Mesothelioma.

Medical terms in this study, explained in our Lexicon: Clinical Trial, Indwelling Pleural Catheter, Trapped Lung, Pleural Mesothelioma, Pleural Effusion, Visceral Pleura, Pleurectomy/Decortication (P/D).

Related studies

• The MesoVATS trial: is there a future for video-assisted thoracoscopic surgery partial pleurectomy? — R.C. Rintoul (2015)
• Protocol of the Australasian Malignant Pleural Effusion-2 (AMPLE-2) trial: a multicentre randomised study of aggressive versus symptom-guided drainage via indwelling pleural catheters — M. Azzopardi, R. Thomas, et al. (2016)
• Video-assisted management of malignant pleural effusion in breast carcinoma — R. Gasparri, F. Leo, et al. (2006)
• Aggressive versus symptom-guided drainage of malignant pleural effusion via indwelling pleural catheters (AMPLE-2): an open-label randomised trial — S. Muruganandan, M. Azzopardi, et al. (2018)
• Predictors of clinical use of pleurodesis and/or indwelling pleural catheter therapy for malignant pleural effusion — E.T.H. Fysh, S. Bielsa, et al. (2015)
• Indwelling pleural catheter versus talc pleurodesis for malignant pleural effusion: a meta-analysis — M. Yeung, E.W. Loh, et al. (2020)

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