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

Malignant Pleural Mesothelioma Clinical Trial

— MesoTRAP  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03412357
• Other study ID #: PO2128
• Status: Completed
• Phase: N/A
• Start date: August 10, 2017
• Est. completion date: August 1, 2020

Study information

• Verified date: September 2020
• Source: Papworth Hospital NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: August 1, 2020
• Est. primary completion date: March 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Malignant Pleural Mesothelioma
• Mesothelioma
• Pleural Effusion
• Trapped Lung

Intervention

Procedure:
• pleurectomy/decortication
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.
• 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.

Locations

Country	Name	City	State
United Kingdom	Blackpool Teaching Hospitals NHS Foundation Trust	Blackpool
United Kingdom	North Bristol NHS Trust	Bristol
United Kingdom	Cambridge University Hospitals	Cambridge
United Kingdom	Papworth Hospital NHS Foundation Trust	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	University Hospitals of Leicester	Leicester
United Kingdom	Barts Health NHS Trust	London
United Kingdom	Manchester University NHS Foundation Trust	Manchester
United Kingdom	Pennine Acute Hospitals NHS Trust	Manchester
United Kingdom	Norfolk and Norwich University Hospitals NHS Foundation Trust	Norwich
United Kingdom	Nottingham University Hospitals NHS Trust	Nottingham
United Kingdom	Oxford University Hospitals	Oxford
United Kingdom	North West Anglia NHS Foundation Trust	Peterborough
United Kingdom	Lancashire Teaching Hospitals NHS Foundation Trust	Preston
United Kingdom	Sheffield Teaching Hospitals	Sheffield
United Kingdom	University Hospitals of North Midlands NHS Trust	Stoke-on-Trent

Sponsors (5)

Lead Sponsor	Collaborator
Papworth Hospital NHS Foundation Trust	King's College London, London School of Hygiene and Tropical Medicine, National Institute for Health Research, United Kingdom, University of Sheffield

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To measure the standard deviation of Visual Analogue Scale scores for breathlessness	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".	Daily from randomisation to 12 months
Secondary	To measure the standard deviation of Visual Analogue Scale scores for chest pain	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".	Daily from randomisation to 12 months
Secondary	Quality of Life measured using the EQ-5D-5L		Baseline, intervention, 6 weeks, 3, 6 and 12 months post randomisation
Secondary	Quality of Life measured using the EORTC QLQC30		Baseline, intervention, 6 weeks, 3, 6 and 12 months post randomisation
Secondary	Survival at 30 days and 12 months post randomisation		30 days and 12 months post randomisation
Secondary	Adverse events		From randomisation to the end of study follow-up (expected to be 12 months)
Secondary	The prevalence of trapped lung in patients with MPM		From beginning to end of recruitment period (18 months)
Secondary	Percentage of eligible patients in participating centres		From beginning to end of recruitment period (18 months)
Secondary	Recruitment rate		From beginning to end of recruitment period (18 months)
Secondary	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