MesoTRAP: A Study Comparing Video-assisted Thoracoscopic Partial Pleurectomy/Decortication With Indwelling Pleural Catheter in Patients With Trapped Lung Due to Malignant Pleural Mesothelioma.

Not Applicable

Completed

• Conditions: Malignant Pleural Mesothelioma; Trapped Lung
• Interventions: Procedure: indwelling pleural catheter; Procedure: pleurectomy/decortication

• Registration Number: NCT03412357
• Lead Sponsor: Papworth Hospital NHS Foundation Trust

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.

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 pleural catheter (IPC) in patients with trapped lung (TL) and pleural effusion due to malignant pleural mesothelioma (MPM), aimed at addressing recruitment and randomisation uncertainties as well as sample size requirements for a full phase III study. 38 patients will be randomised and allocated in a 1:1 ratio to either VAT-PD or IPC.

The study will be undertaken at mesothelioma surgical centres with expertise in either IPC, VAT-PD or both procedures, together with their linked non-surgical referral hospitals (hub and spoke). Patients meeting all eligibility criteria will be informed about the study, provided with a patient information sheet and given at least 24 hours to consider participation.

Following consent, patients will be randomised, baseline measurements will be taken and a procedure date will be arranged. Following the procedure follow-up visits at 6 weeks, 3, 6 and 12 months post-randomisation are planned to coincide with clinical care visits.

In parallel with the main study an observational sub-study will collect observational data on a cohort of patients who have Malignant Pleural Mesothelioma and trapped lung, but who are either not eligible to participate, or who decline to participate in the main study. Patients in the Observational Sub-study will receive the same baseline and follow-up visits as those in the main study, but will receive standard clinical care.

Study Timeline

• Study Start: 2017-08-10
• Study First Submitted: 2017-11-29
• Study First Submitted QC: 2018-01-25
• Study First Posted: 2018-01-26
• Primary Completion: 2020-03-31
• Study Completion: 2020-08-01
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-15
• Last Update Posted: 2020-09-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

Inclusion Criteria

1. Pathologically confirmed MPM
2. Trapped lung, defined as a 'clinically significant trapped lung requiring intervention in the opinion of the clinical team"
3. Pleural effusion present (following re-accumulation)
4. Considered by the clinical team to be suitable and fit enough to undergo VAT-PD
5. Community services or patient/carer able to drain IPC at least twice weekly
6. Considered by the clinical team to be equally suitable for treatment with VAT-PD or IPC, and therefore eligible for treatment allocation by randomisation.
7. Patient willing to receive either VAT-PD or IPC and attend the respective designated centre for their treatment
8. Expected survival of at least 4 months, as assessed by managing clinician
9. Age ≥ 18 years
10. Able to provide informed consent

Exclusion Criteria

1. Lung re-expands fully following pleural fluid drainage i.e. no entrapment
2. Evidence of active pleural infection
3. Current participation in an RCT or CTIMP
4. Females: pregnant or lactating

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
indwelling pleural catheter	indwelling pleural catheter	-
pleurectomy/decortication	pleurectomy/decortication	-

Primary Outcome Measures

Name	Time	Method
To measure the standard deviation of Visual Analogue Scale scores for breathlessness	Daily from randomisation to 12 months	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".

Secondary Outcome Measures

Name	Time	Method
To measure the standard deviation of Visual Analogue Scale scores for chest pain	Daily from randomisation to 12 months	The Visual Analogue Scale (VAS) is a 100mm line for patients to record the severity of a their chest pain where 0mm is "No pain at all" and 100mm is "Worst possible pain".
Quality of Life measured using the EQ-5D-5L	Baseline, intervention, 6 weeks, 3, 6 and 12 months post randomisation
To assess completion of resource use data during follow-up using patients' routine data	Baseline, intervention, 6 weeks, 3, 6 and 12 months post randomisation
The prevalence of trapped lung in patients with MPM	From beginning to end of recruitment period (18 months)
Recruitment rate	From beginning to end of recruitment period (18 months)
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
Percentage of eligible patients in participating centres	From beginning to end of recruitment period (18 months)
Adverse events	From randomisation to the end of study follow-up (expected to be 12 months)

Trial Locations

Locations (18)

Barts Health NHS Trust; 🇬🇧 London, United Kingdom

North Bristol NHS Trust; 🇬🇧 Bristol, United Kingdom

Papworth Hospital NHS Foundation Trust; 🇬🇧 Cambridge, 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

Pennine Acute Hospitals NHS Trust; 🇬🇧 Manchester, United Kingdom

University Hospitals of Leicester; 🇬🇧 Leicester, United Kingdom

Norfolk and Norwich University Hospitals NHS Foundation Trust; 🇬🇧 Norwich, United Kingdom

Manchester University NHS Foundation Trust; 🇬🇧 Manchester, United Kingdom

Nottingham University Hospitals NHS Trust; 🇬🇧 Nottingham, United Kingdom

Sheffield Teaching Hospitals; 🇬🇧 Sheffield, United Kingdom

North West Anglia NHS Foundation Trust; 🇬🇧 Peterborough, United Kingdom

Oxford University Hospitals; 🇬🇧 Oxford, United Kingdom

Lancashire Teaching Hospitals NHS Foundation Trust; 🇬🇧 Preston, United Kingdom

University Hospitals of North Midlands NHS Trust; 🇬🇧 Stoke-on-Trent, United Kingdom

Blackpool Teaching Hospitals NHS Foundation Trust; 🇬🇧 Blackpool, United Kingdom