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)

September 15, 2020 updated by: Papworth Hospital NHS Foundation Trust

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

23

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Blackpool, United Kingdom
        • Blackpool Teaching Hospitals NHS Foundation Trust
      • Bristol, United Kingdom
        • North Bristol NHS Trust
      • Cambridge, United Kingdom
        • Cambridge University Hospitals
      • Cambridge, United Kingdom, CB23 5EF
        • Papworth Hospital NHS Foundation Trust
      • Derby, United Kingdom
        • Derby Teaching Hospitals NHS Foundation Trust
      • Glasgow, United Kingdom
        • Golden Jubilee National Hospital
      • Glasgow, United Kingdom
        • Queen Elizabeth University Hospital and New Victoria Hospital
      • Leicester, United Kingdom
        • University Hospitals of Leicester
      • London, United Kingdom
        • Barts Health NHS Trust
      • Manchester, United Kingdom
        • Manchester University NHS Foundation Trust
      • Manchester, United Kingdom
        • Pennine Acute Hospitals NHS Trust
      • Norwich, United Kingdom
        • Norfolk and Norwich University Hospitals NHS Foundation Trust
      • Nottingham, United Kingdom
        • Nottingham University Hospitals NHS Trust
      • Oxford, United Kingdom
        • Oxford University Hospitals
      • Peterborough, United Kingdom
        • North West Anglia NHS Foundation Trust
      • Preston, United Kingdom
        • Lancashire Teaching Hospitals NHS Foundation Trust
      • Sheffield, United Kingdom
        • Sheffield Teaching Hospitals
      • Stoke-on-Trent, United Kingdom
        • University Hospitals of North Midlands NHS Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: pleurectomy/decortication
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.
Other Names:
  • video-assisted thoracoscopic partial pleurectomy/decortication
  • VAT-PD
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 Names:
  • IPC

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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".
Daily from randomisation to 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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".
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
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
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
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)
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)
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)
From beginning to end of recruitment period (18 months)
Recruitment rate
Time Frame: From beginning to end of recruitment period (18 months)
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
Baseline, intervention, 6 weeks, 3, 6 and 12 months post randomisation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Papworth Hospital NHS Foundation Trust

Collaborators

London School of Hygiene and Tropical Medicine
King's College London
University of Sheffield
National Institute for Health Research, United Kingdom

Investigators

  • Principal Investigator: Robert Rintoul, Dr, Papworth Hospital NHS Foundation Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 10, 2017

Primary Completion (ACTUAL)

March 31, 2020

Study Completion (ACTUAL)

August 1, 2020

Study Registration Dates

First Submitted

November 29, 2017

First Submitted That Met QC Criteria

January 25, 2018

First Posted (ACTUAL)

January 26, 2018

Study Record Updates

Last Update Posted (ACTUAL)

September 16, 2020

Last Update Submitted That Met QC Criteria

September 15, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PO2128

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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