MesoTRAP: A Study Comparing Video-assisted Thoracoscopic Partial Pleurectomy/Decortication With Indwelling Pleural Catheter in Patients With Trapped Lung Due to Malignant Pleural Mesothelioma.
MesoTRAP
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.
1 other identifier
interventional
23
1 country
18
Brief Summary
Malignant pleural mesothelioma is a cancer, caused by asbestos, which currently affects 2500 people in the UK each year. The main symptom is breathlessness caused by fluid building up in the space between the lung and the chest wall (pleural effusion). Treatment involves draining the fluid to allow the lung to re-expand (pleurodesis). However, sometimes tumour growth over the surface of the lung can prevent it from re-expanding. This 'trapped' lung results in fluid re-accumulation and repeated drainage which can lead to discomfort and multiple hospital visits. One approach to dealing with 'trapped' lung in mesothelioma is to insert a thin tube (Indwelling Pleural Catheter - IPC) into the space around the lung. The tube can stay in place for a long time allowing patients to drain off fluid at home. Another approach is a keyhole surgical operation (video-assisted thoracoscopic partial pleurectomy/decortication - VAT-PD) to remove as much tumour as possible from the lining of the lung to allow it to re-expand. 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. The Investigators plan to do this, but first of all need to carry out a small pilot study to collect information necessary to help plan the full study.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 2017
Typical duration for not_applicable
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 10, 2017
CompletedFirst Submitted
Initial submission to the registry
November 29, 2017
CompletedFirst Posted
Study publicly available on registry
January 26, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2020
CompletedSeptember 16, 2020
September 1, 2020
2.6 years
November 29, 2017
September 15, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To measure the standard deviation of Visual Analogue Scale scores for breathlessness
The Visual Analogue Scale (VAS) is a 100mm line for patients to record the severity of a their breathlessness where 0mm is "No breathlessness at all" and 100mm is "Worst possible breathlessness".
Daily from randomisation to 12 months
Secondary Outcomes (9)
To measure the standard deviation of Visual Analogue Scale scores for chest pain
Daily from randomisation to 12 months
Quality of Life measured using the EQ-5D-5L
Baseline, intervention, 6 weeks, 3, 6 and 12 months post randomisation
Quality of Life measured using the EORTC QLQC30
Baseline, intervention, 6 weeks, 3, 6 and 12 months post randomisation
Survival at 30 days and 12 months post randomisation
30 days and 12 months post randomisation
Adverse events
From randomisation to the end of study follow-up (expected to be 12 months)
- +4 more secondary outcomes
Study Arms (2)
pleurectomy/decortication
EXPERIMENTALindwelling pleural catheter
EXPERIMENTALInterventions
VAT-PD is a type of "keyhole surgery" performed under general anaesthesia using a telescope and instruments put inside the chest. Through small incisions, or keyholes made between the ribs, the thoracic surgeon removes the hard rind of the tumour over the surface of the lung, thereby allowing the 'trapped' lung to fully expand again. Simultaneous removal of mesothelioma from the outer pleural membrane allows pleurodesis to occur.
A soft silicone catheter (IPC) with a one-way valve at the end is inserted a few centimetres under the skin under local anaesthesia. The inside end of the catheter is inserted into the pleural space and the outside end is connected to a vacuum drainage bottle. The IPC permits regular fluid drainage.
Eligibility Criteria
You may qualify if:
- Pathologically confirmed MPM
- Trapped lung, defined as a 'clinically significant trapped lung requiring intervention in the opinion of the clinical team"
- Pleural effusion present (following re-accumulation)
- Considered by the clinical team to be suitable and fit enough to undergo VAT-PD
- Community services or patient/carer able to drain IPC at least twice weekly
- Considered by the clinical team to be equally suitable for treatment with VAT-PD or IPC, and therefore eligible for treatment allocation by randomisation.
- Patient willing to receive either VAT-PD or IPC and attend the respective designated centre for their treatment
- Expected survival of at least 4 months, as assessed by managing clinician
- Age ≥ 18 years
- Able to provide informed consent
You may not qualify if:
- Lung re-expands fully following pleural fluid drainage i.e. no entrapment
- Evidence of active pleural infection
- Current participation in an RCT or CTIMP
- Females: pregnant or lactating
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Papworth Hospital NHS Foundation Trustlead
- National Institute for Health Research, United Kingdomcollaborator
- London School of Hygiene and Tropical Medicinecollaborator
- King's College Londoncollaborator
- University of Sheffieldcollaborator
Study Sites (18)
Blackpool Teaching Hospitals NHS Foundation Trust
Blackpool, United Kingdom
North Bristol NHS Trust
Bristol, United Kingdom
Papworth Hospital NHS Foundation Trust
Cambridge, CB23 5EF, United Kingdom
Cambridge University Hospitals
Cambridge, United Kingdom
Derby Teaching Hospitals NHS Foundation Trust
Derby, United Kingdom
Golden Jubilee National Hospital
Glasgow, United Kingdom
Queen Elizabeth University Hospital and New Victoria Hospital
Glasgow, United Kingdom
University Hospitals of Leicester
Leicester, United Kingdom
Barts Health NHS Trust
London, United Kingdom
Manchester University NHS Foundation Trust
Manchester, United Kingdom
Pennine Acute Hospitals NHS Trust
Manchester, United Kingdom
Norfolk and Norwich University Hospitals NHS Foundation Trust
Norwich, United Kingdom
Nottingham University Hospitals NHS Trust
Nottingham, United Kingdom
Oxford University Hospitals
Oxford, United Kingdom
North West Anglia NHS Foundation Trust
Peterborough, United Kingdom
Lancashire Teaching Hospitals NHS Foundation Trust
Preston, United Kingdom
Sheffield Teaching Hospitals
Sheffield, United Kingdom
University Hospitals of North Midlands NHS Trust
Stoke-on-Trent, United Kingdom
Related Publications (1)
Matthews C, Freeman C, Sharples LD, Fox-Rushby J, Tod A, Maskell NA, Edwards JG, Coonar AS, Sivasothy P, Hughes V, Rahman NM, Waller DA, Rintoul RC. 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. BMJ Open Respir Res. 2019 Jan 5;6(1):e000368. doi: 10.1136/bmjresp-2018-000368. eCollection 2019.
PMID: 30687504DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Robert Rintoul, Dr
Papworth Hospital NHS Foundation Trust
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 29, 2017
First Posted
January 26, 2018
Study Start
August 10, 2017
Primary Completion
March 31, 2020
Study Completion
August 1, 2020
Last Updated
September 16, 2020
Record last verified: 2020-09