Skip to main content
OpenTrials
Completed

NCT Number: NCT03412357

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 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Malignant Pleural Mesothelioma Adenoma Lung Diseases Lung Neoplasms Mesothelioma Mesothelioma, Malignant Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Neoplasms, Mesothelial Pleural Neoplasms Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms Trapped Lung

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Blackpool Teaching Hospitals NHS Foundation Trust, Blackpool, United Kingdom

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Pleurectomy/Decortication

Procedure

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

indwelling pleural catheter

Procedure

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

Primary outcomes

  1. 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".

Secondary outcomes

  1. 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".

  2. Quality of Life measured using the EQ-5D-5L

    Time frame: Baseline, intervention, 6 weeks, 3, 6 and 12 months post randomisation

  3. Quality of Life measured using the EORTC QLQC30

    Time frame: Baseline, intervention, 6 weeks, 3, 6 and 12 months post randomisation

  4. Survival at 30 days and 12 months post randomisation

    Time frame: 30 days and 12 months post randomisation

  5. Adverse events

    Time frame: From randomisation to the end of study follow-up (expected to be 12 months)

  6. The prevalence of trapped lung in patients with MPM

    Time frame: From beginning to end of recruitment period (18 months)

  7. Percentage of eligible patients in participating centres

    Time frame: From beginning to end of recruitment period (18 months)

  8. Recruitment rate

    Time frame: From beginning to end of recruitment period (18 months)

  9. 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

Sponsors and collaborators

Lead sponsor

Papworth Hospital NHS Foundation Trust

Other Gov

Collaborators

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

Registry information

Official study 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.

Acronym: MesoTRAP

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Jan 26, 2018
Registry last updated
Sep 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.