MesoTRAP pilot clinical trial and feasibility study
Research type
Research Study
Full title
MesoTRAP: A pilot clinical trial and feasibility study 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.
IRAS ID
198596
Contact name
Robert Rintoul
Contact email
Sponsor organisation
Papworth Hospital NHS Foundation Trust
Duration of Study in the UK
2 years, 11 months, 31 days
Research summary
Malignant pleural mesothelioma is a cancer, caused by asbestos, affecting 2500 UK patients each year. The main symptom is breathlessness caused by fluid building up in the space between the lung and the chest wall. Treatment involves draining fluid to allow the lung to re-expand. However, sometimes tumour growing over the surface of the lung prevents it from re-expanding. This ‘trapped’ lung results in fluid re-accumulation and repeated drainage leading to significant patient distress and multiple hospital visits.
One approach to dealing with ‘trapped’ lung in mesothelioma is to insert a thin tube (Indwelling Pleural Catheter) into the space around the lung. The tube can stay in place for a long time allowing patients to drain off fluid at home. The other approach is a keyhole surgical operation to remove as much tumour as possible from the lining of the lung to allow it to re-expand. We do not know which of these two approaches is more effective at relieving breathlessness. While both approaches are currently offered in clinical practice, it is not known which of the two is most effective at relieving breathlessness. The only way to find out is to conduct a research trial comparing the two.
We plan to do this, but first of all we need to carry out a small pilot study to collect information necessary to help us plan the full trial. A sub-study will find out what patients think about the trial in order to improve how we run the full-scale study.
Research into breathlessness caused by mesothelioma has been identified by the James Lind Alliance Priority Setting Partnership. We received advice on study design from patients/carers and patient support groups. We will make our findings known through patient support groups, scientific journals, national and international conferences.REC name
East of England - Cambridge Central Research Ethics Committee
REC reference
16/EE/0370
Date of REC Opinion
2 Dec 2016
REC opinion
Further Information Favourable Opinion