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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
Sponsor:
Collaborators:
National Institute for Health Research, United Kingdom
London School of Hygiene and Tropical Medicine
King's College London
University of Sheffield
Information provided by (Responsible Party):
Papworth Hospital NHS Foundation Trust

Brief 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.


Condition or disease Intervention/treatment Phase
Malignant Pleural Mesothelioma Trapped Lung Procedure: pleurectomy/decortication Procedure: indwelling pleural catheter Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mesothelioma

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 Name: IPC




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Contacts
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Contact: Carol Freeman 0044 1480 366321 carolfreeman@nhs.net
Contact: Claire Matthews 0044 1480 364788 claire.matthews5@nhs.net

Locations
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United Kingdom
Blackpool Teaching Hospitals NHS Foundation Trust Recruiting
Blackpool, United Kingdom
Contact: Nidal Bittar       Mr.Bittar@bfwhospitals.nhs.uk   
North Bristol NHS Trust Recruiting
Bristol, United Kingdom
Contact: Nick Maskell         
Contact: nick.maskell@bristol.ac.uk         
Papworth Hospital NHS Foundation Trust Recruiting
Cambridge, United Kingdom, CB23 5EF
Contact: Robert Rintoul    0044 1480 364342    robert.rintoul@nhs.net   
Cambridge University Hospitals Recruiting
Cambridge, United Kingdom
Contact: Jurgen Herre       Jurgen.Herre@addenbrookes.nhs.uk   
Derby Teaching Hospitals NHS Foundation Trust Recruiting
Derby, United Kingdom
Contact: Paul Beckett       paul.beckett1@nhs.net   
Golden Jubilee National Hospital Recruiting
Glasgow, United Kingdom
Contact: Alan Kirk         
Contact: Alan.kirk@gjnh.scot.nhs.uk         
Queen Elizabeth University Hospital and New Victoria Hospital Recruiting
Glasgow, United Kingdom
Contact: Kevin Blyth       kevin.blyth@ggc.scot.nhs.uk   
University Hospitals of Leicester Recruiting
Leicester, United Kingdom
Contact: Apostolos Nakas       apostolos.nakas@uhl-tr.nhs.uk   
Barts Health NHS Trust Recruiting
London, United Kingdom
Contact: Kelvin Lau       kelvin.lau@bartshealth.nhs.uk   
Manchester University NHS Foundation Trust Recruiting
Manchester, United Kingdom
Contact: Matthew Evison       Matthew.Evison@MFT.NHS.UK   
Pennine Acute Hospitals NHS Trust Recruiting
Manchester, United Kingdom
Contact: Louise Brown       Louise.Brown2@pat.nhs.uk   
Norfolk and Norwich University Hospitals NHS Foundation Trust Recruiting
Norwich, United Kingdom
Contact: Eleanor Mishra       eleanor.mishra@nnuh.nhs.uk   
Nottingham University Hospitals NHS Trust Recruiting
Nottingham, United Kingdom
Contact: Helen Roberts       Helen.Roberts3@nuh.nhs.uk   
Oxford University Hospitals Recruiting
Oxford, United Kingdom
Contact: Dio Stravoulis         
Contact: dio.stravoulis@ouh.nhs.uk         
North West Anglia NHS Foundation Trust Recruiting
Peterborough, United Kingdom
Contact: Pasupathy Sivasothy         
Contact: Pasupathy-Rajah.Sivasothy@pbh-tr.nhs.uk         
Lancashire Teaching Hospitals NHS Foundation Trust Recruiting
Preston, United Kingdom
Contact: Mohammed Munavvar       Mohammed.Munavvar@lthtr.nhs.uk   
Sheffield Teaching Hospitals Recruiting
Sheffield, United Kingdom
Contact: John Edwards       John.Edwards@sth.nhs.uk   
University Hospitals of North Midlands NHS Trust Recruiting
Stoke-on-Trent, United Kingdom
Contact: Shahul Khan       Shahul.Khan@uhnm.nhs.uk   
Sponsors and Collaborators
Papworth Hospital NHS Foundation Trust
National Institute for Health Research, United Kingdom
London School of Hygiene and Tropical Medicine
King's College London
University of Sheffield
Investigators
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Principal Investigator: Robert Rintoul, Dr Papworth Hospital NHS Foundation Trust

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Papworth Hospital NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT03412357     History of Changes
Other Study ID Numbers: PO2128
First Posted: January 26, 2018    Key Record Dates
Last Update Posted: January 28, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Papworth Hospital NHS Foundation Trust:
pleurectomy/decortication
indwelling pleural catheter
Additional relevant MeSH terms:
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Mesothelioma
Pleural Effusion
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Mesothelial
Pleural Diseases
Respiratory Tract Diseases