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.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 19
- 主要终点
- To measure the standard deviation of Visual Analogue Scale scores for breathlessness
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
To measure the standard deviation of Visual Analogue Scale scores for breathlessness
时间窗: 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".
次要结局
- Quality of Life measured using the EQ-5D-5L(Baseline, intervention, 6 weeks, 3, 6 and 12 months post randomisation)
- To measure the standard deviation of Visual Analogue Scale scores for chest pain(Daily from randomisation to 12 months)
- 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))