Status:
COMPLETED
MesoTRAP: A Study Comparing Video-assisted Thoracoscopic Partial Pleurectomy/Decortication With Indwelling Pleural Catheter in Patients With Trapped Lung Due to Malignant Pleural Mesothelioma.
Lead Sponsor:
Papworth Hospital NHS Foundation Trust
Collaborating Sponsors:
National Institute for Health Research, United Kingdom
London School of Hygiene and Tropical Medicine
Conditions:
Malignant Pleural Mesothelioma
Trapped Lung
Eligibility:
All Genders
18+ years
Phase:
NA
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 bet...
Detailed Description
This is a multi-centre, open-label, randomised controlled pilot clinical trial and feasibility study comparing video-assisted thoracoscopic partial pleurectomy/decortication (VAT-PD) with indwelling p...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
August 10 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2020
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT03412357
Start Date
August 10 2017
End Date
August 1 2020
Last Update
September 16 2020
Active Locations (18)
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1
Blackpool Teaching Hospitals NHS Foundation Trust
Blackpool, United Kingdom
2
North Bristol NHS Trust
Bristol, United Kingdom
3
Papworth Hospital NHS Foundation Trust
Cambridge, United Kingdom, CB23 5EF
4
Cambridge University Hospitals
Cambridge, United Kingdom