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)

Please note: the estimated primary completion date for this study of December, 2018 has passed. However, it is not listed as closed by ClinicalTrials.gov. Inquire with the study contacts (listed below) to determine if they are still accepting participants or for more information about the treatment protocol.

Purpose: 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 catheterIPC) 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.

Primary Outcome Measures

  • To measure the standard deviation of Visual Analogue Scale scores for breathlessness [ Time Frame: 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

  • o measure the standard deviation of Visual Analogue Scale scores for chest pain [ Time Frame: 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 [ Time Frame: Baseline, intervention, 6 weeks, 3, 6 and 12 months post randomisation ]
  • Quality of Life measured using the EORTC QLQC30 [ Time Frame: Baseline, intervention, 6 weeks, 3, 6 and 12 months post randomisation ]
  • Survival at 30 days and 12 months post randomisation [ Time Frame: 30 days and 12 months post randomisation ]
  • Adverse events [ Time Frame: From randomisation to the end of study follow-up (expected to be 12 months) ]
  • The prevalence of trapped lung in patients with MPM [ Time Frame: From beginning to end of recruitment period (18 months) ]
  • Percentage of eligible patients in participating centres [ Time Frame: From beginning to end of recruitment period (18 months) ]
  • Recruitment rate [ Time Frame: From beginning to end of recruitment period (18 months) ]
  • To assess completion of resource use data during follow-up using patients’ routine data [ Time Frame: Baseline, intervention, 6 weeks, 3, 6 and 12 months post randomisation ]

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.

Eligibility

Inclusion Criteria
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 Criteria
Lung re-expands fully following pleural fluid drainage i.e. no entrapment

Previous attempt at pleurodesis on ipsilateral side

Evidence of active pleural infection

IPC in situ for more than 28 days

Current participation in an RCT or CTIMP

Females: pregnant or lactating

« Mesothelioma Clinical Trials Main Page.

Source: the U.S. National Institutes of Health via ClinicalTrials.gov. Last updated: February 8th, 2018.

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Last update: May 07, 2019. 08:38:48 pm.