Malignant Pleural MesotheliomaMesoTRAPNCT03412357
MesoTRAP: A Study Comparing Video-assisted Thoracoscopic Partial Pleurectomy/Decortication With Indwelling Pleural Catheter in Patients With Trapped Lung Due to Malignant Pleural Mesothelioma.
A study testing pleurectomy/decortication and indwelling pleural catheter in people with Malignant Pleural Mesothelioma and Trapped Lung, run by Papworth Hospital NHS Foundation Trust at 18 sites in United Kingdom.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Pleural Mesothelioma, Trapped Lung
- What is being tested?
- pleurectomy/decortication and indwelling pleural catheter
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 18 sitesUnited Kingdom
- Study dates
- 10 Aug 2017to 1 Aug 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 10Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
United Kingdom18 sites
Blackpool Teaching Hospitals NHS Foundation Trust
Blackpool
North Bristol NHS Trust
Bristol
Papworth Hospital NHS Foundation Trust
Cambridge, CB23 5EF
Cambridge University Hospitals
Cambridge
Derby Teaching Hospitals NHS Foundation Trust
Derby
Golden Jubilee National Hospital
Glasgow
Queen Elizabeth University Hospital and New Victoria Hospital
Glasgow
University Hospitals of Leicester
Leicester
Barts Health NHS Trust
London
Manchester University NHS Foundation Trust
Manchester
Pennine Acute Hospitals NHS Trust
Manchester
Norfolk and Norwich University Hospitals NHS Foundation Trust
Norwich
Nottingham University Hospitals NHS Trust
Nottingham
Oxford University Hospitals
Oxford
North West Anglia NHS Foundation Trust
Peterborough
Lancashire Teaching Hospitals NHS Foundation Trust
Preston
Sheffield Teaching Hospitals
Sheffield
University Hospitals of North Midlands NHS Trust
Stoke-on-Trent
About this study
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.
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.
Read more
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.
Read the 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.
- Conditions
- Malignant Pleural Mesothelioma, Trapped Lung
- Being tested
- pleurectomy/decortication, indwelling pleural catheter
- Keywords
- pleurectomy/decortication, indwelling pleural catheter
- Medical subject headings
- Mesothelioma, Malignant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pleurectomy/decorticationProcedure or surgery
Also called video-assisted thoracoscopic partial pleurectomy/decortication, VAT-PD
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 catheterProcedure or surgery
Also called IPC
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.
| Study group | Role | What they receive |
|---|---|---|
| pleurectomy/decortication | Experimental | Not described Receives: Procedure: pleurectomy/decortication |
| indwelling pleural catheter | Experimental | Not described Receives: Procedure: indwelling pleural catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
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".
Measured: Daily from randomisation to 12 months
Secondary outcomes (9)
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".
Measured: Daily from randomisation to 12 months
Quality of Life measured using the EQ-5D-5L
Measured: Baseline, intervention, 6 weeks, 3, 6 and 12 months post randomisation
Quality of Life measured using the EORTC QLQC30
Measured: Baseline, intervention, 6 weeks, 3, 6 and 12 months post randomisation
Survival at 30 days and 12 months post randomisation
Measured: 30 days and 12 months post randomisation
Adverse events
Measured: From randomisation to the end of study follow-up (expected to be 12 months)
The prevalence of trapped lung in patients with MPM
Measured: From beginning to end of recruitment period (18 months)
Percentage of eligible patients in participating centres
Measured: From beginning to end of recruitment period (18 months)
Recruitment rate
Measured: From beginning to end of recruitment period (18 months)
To assess completion of resource use data during follow-up using patients' routine data
Measured: Baseline, intervention, 6 weeks, 3, 6 and 12 months post randomisation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2018
- Study start10 Aug 2017
- Primary completion31 Mar 2020
- Study completion1 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Malignant Pleural MesotheliomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Papworth Hospital NHS Foundation Trust
- Sponsor type
- Other government
- Collaborators
- National Institute for Health Research, United Kingdom, London School of Hygiene and Tropical Medicine, King's College London, University of Sheffield
- Responsible party
- Sponsor
- Investigators
- Robert Rintoul, Dr, Principal investigator, Papworth Hospital NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03412357
- Sponsor's protocol ID
- PO2128
- Acronym
- MesoTRAP
- Status last verified
- Sep 2020
- First submitted
- 29 Nov 2017
- Last updated
- 16 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 30687504
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03412357
- Acronym / sponsor ID
- MesoTRAP / PO2128
- Conditions
- Malignant Pleural Mesothelioma, Trapped Lung
- Keywords
- pleurectomy/decortication, indwelling pleural catheter
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Papworth Hospital NHS Foundation TrustOther government
- Collaborators
- National Institute for Health Research, United Kingdom, London School of Hygiene and Tropical Medicine, King's College London, University of Sheffield
- Study start
- 10 Aug 2017 (actual)
- Primary completion
- 31 Mar 2020 (actual)
- Study completion
- 1 Aug 2020 (actual)
- First posted
- 26 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pleurectomy/decortication | Experimental | Procedure: pleurectomy/decortication |
| indwelling pleural catheter | Experimental | Procedure: indwelling pleural catheter |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pleurectomy/decorticationAlso: video-assisted thoracoscopic partial pleurectomy/decortication, VAT-PDVAT-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. | Procedure or surgery | pleurectomy/decortication |
| indwelling pleural catheterAlso: IPCA 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. | Procedure or surgery | indwelling pleural catheter |
Primary outcome
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".
9 secondary outcomes
To measure the standard deviation of Visual Analogue Scale scores for chest pain
Time frame: Daily from randomisation to 12 months
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2020.
- Derived from this study: PubMed 30687504Matthews 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Rintoul, Dr principal investigator
Papworth Hospital NHS Foundation Trust
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pleurectomy/decortication and indwelling pleural catheter in people with Malignant Pleural Mesothelioma and Trapped Lung, run by Papworth Hospital NHS Foundation Trust at 18 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To measure the standard deviation of Visual Analogue Scale scores for breathlessness (time frame: Daily from randomisation to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03412357, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2020.