Clinical trial NCT03412357: MesoTRAP: A Study Comparing Video-assisted Thoracoscopic Partial Pleurectomy/Decortication With Indwelling Pleural Catheter in Patients With Trapped Lung Due to Malignant Pleural Mesothelioma.
Official 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malignant Pleural Mesothelioma
Trapped Lung
Keywords: pleurectomy/decortication
indwelling pleural catheter
Lead sponsor: Papworth Hospital NHS Foundation Trust
Sponsor class: OTHER_GOV
Collaborators: name: National Institute for Health Research, United Kingdom
name: London School of Hygiene and Tropical Medicine
name: King's College London
name: University of Sheffield
First posted: 2018-01-26
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: To measure the standard deviation of Visual Analogue Scale scores for breathlessness
timeFrame: Daily from randomisation to 12 months
Secondary outcomes:
measure: To measure the standard deviation of Visual Analogue Scale scores for chest pain
timeFrame: Daily from randomisation to 12 months
measure: Quality of Life measured using the EQ-5D-5L
timeFrame: Baseline, intervention, 6 weeks, 3, 6 and 12 months post randomisation
measure: Quality of Life measured using the EORTC QLQC30
timeFrame: Baseline, intervention, 6 weeks, 3, 6 and 12 months post randomisation
measure: Survival at 30 days and 12 months post randomisation
timeFrame: 30 days and 12 months post randomisation
measure: Adverse events
timeFrame: From randomisation to the end of study follow-up (expected to be 12 months)
measure: The prevalence of trapped lung in patients with MPM
timeFrame: From beginning to end of recruitment period (18 months)
measure: Percentage of eligible patients in participating centres
timeFrame: From beginning to end of recruitment period (18 months)
measure: Recruitment rate
timeFrame: From beginning to end of recruitment period (18 months)
measure: To assess completion of resource use data during follow-up using patients' routine data
timeFrame: Baseline, intervention, 6 weeks, 3, 6 and 12 months post randomisation
Other outcomes:
Locations:
city: Blackpool
country: United Kingdom
facility: Blackpool Teaching Hospitals NHS Foundation Trust
city: Bristol
country: United Kingdom
facility: North Bristol NHS Trust
city: Cambridge
country: United Kingdom
facility: Papworth Hospital NHS Foundation Trust
city: Cambridge
country: United Kingdom
facility: Cambridge University Hospitals
city: Derby
country: United Kingdom
facility: Derby Teaching Hospitals NHS Foundation Trust
city: Glasgow
country: United Kingdom
facility: Golden Jubilee National Hospital
city: Glasgow
country: United Kingdom
facility: Queen Elizabeth University Hospital and New Victoria Hospital
city: Leicester
country: United Kingdom
facility: University Hospitals of Leicester
city: London
country: United Kingdom
facility: Barts Health NHS Trust
city: Manchester
country: United Kingdom
facility: Manchester University NHS Foundation Trust
city: Manchester
country: United Kingdom
facility: Pennine Acute Hospitals NHS Trust
city: Norwich
country: United Kingdom
facility: Norfolk and Norwich University Hospitals NHS Foundation Trust
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospitals NHS Trust
city: Oxford
country: United Kingdom
facility: Oxford University Hospitals
city: Peterborough
country: United Kingdom
facility: North West Anglia NHS Foundation Trust
city: Preston
country: United Kingdom
facility: Lancashire Teaching Hospitals NHS Foundation Trust
city: Sheffield
country: United Kingdom
facility: Sheffield Teaching Hospitals
city: Stoke-on-Trent
country: United Kingdom
facility: University Hospitals of North Midlands NHS Trust
Study officials:
affiliation: Papworth Hospital NHS Foundation Trust
name: Robert Rintoul, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.