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)
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|ClinicalTrials.gov Identifier: NCT03412357|
Recruitment Status : Recruiting
First Posted : January 26, 2018
Last Update Posted : January 28, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Malignant Pleural Mesothelioma Trapped Lung||Procedure: pleurectomy/decortication Procedure: indwelling pleural catheter||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||38 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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.|
|Actual Study Start Date :||August 10, 2017|
|Estimated Primary Completion Date :||December 1, 2019|
|Estimated Study Completion Date :||December 1, 2020|
VAT-PD is a type of "keyhole surgery" performed under general anaesthesia using a telescope and instruments put inside the chest. Through small incisions, or keyholes made between the ribs, the thoracic surgeon removes the hard rind of the tumour over the surface of the lung, thereby allowing the 'trapped' lung to fully expand again. Simultaneous removal of mesothelioma from the outer pleural membrane allows pleurodesis to occur.
|Experimental: indwelling pleural catheter||
Procedure: indwelling pleural catheter
A soft silicone catheter (IPC) with a one-way valve at the end is inserted a few centimetres under the skin under local anaesthesia. The inside end of the catheter is inserted into the pleural space and the outside end is connected to a vacuum drainage bottle. The IPC permits regular fluid drainage.
Other Name: IPC
- 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".
- To 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03412357
|Contact: Carol Freeman||0044 1480 firstname.lastname@example.org|
|Contact: Claire Matthews||0044 1480 email@example.com|
|Principal Investigator:||Robert Rintoul, Dr||Papworth Hospital NHS Foundation Trust|