MesoTRAP: A Study Comparing Video-assisted Thoracoscopic Partial Pleurectomy/Decortication With Indwelling Pleural Catheter in Patients With Trapped Lung Due to Malignant Pleural Mesothelioma.
NCT ID: NCT03412357
Last Updated: 2020-09-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
23 participants
INTERVENTIONAL
2017-08-10
2020-08-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Video-Assisted Surgery or Talc Pleurodesis in Treating Patients With Malignant Mesothelioma
NCT00821860
Multicentre Study Comparing Indwelling Pleural Catheter With Talc Pleurodesis for Malignant Pleural Effusion Management
NCT02045121
Manometry vs Clinical Assessment in the Detection of Trapped Lung in Patients With Suspected Pleural Malignancy
NCT02805062
Out Patient Talc Slurry Via Indwelling Pleural Catheter for Malignant Pleural Effusion Vs Usual Inpatient Management
NCT02517749
Alteplase Through an Indwelling Pleural Catheter for the Management of Symptomatic Septated Malignant Pleural Effusion
NCT06184321
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
pleurectomy/decortication
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
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
2. Evidence of active pleural infection
3. Current participation in an RCT or CTIMP
4. Females: pregnant or lactating
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Institute for Health Research, United Kingdom
OTHER_GOV
London School of Hygiene and Tropical Medicine
OTHER
King's College London
OTHER
University of Sheffield
OTHER
Papworth Hospital NHS Foundation Trust
OTHER_GOV
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Robert Rintoul, Dr
Role: PRINCIPAL_INVESTIGATOR
Papworth Hospital NHS Foundation Trust
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Blackpool Teaching Hospitals NHS Foundation Trust
Blackpool, , United Kingdom
North Bristol NHS Trust
Bristol, , United Kingdom
Papworth Hospital NHS Foundation Trust
Cambridge, , United Kingdom
Cambridge University Hospitals
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, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
PO2128
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.