Malignant Pleural Effusion (MPE) is a collection of fluid inside the chest caused by cancer. It is a common medical problem and often causes severe breathlessness. Patients with this condition generally have a very poor survival and so it is extremely important that they are given effective treatment as soon as possible to minimise the amount of time they have to spend in hospital. Standard treatment for MPE involves an admission to hospital to drain the fluid and then attempt to prevent the fluid from returning by sticking the lung to the inside of the rib cage with medical talc powder which acts like glue. This is called talc pleurodesis (TP) but unfortunately it fails in about 30% of patients. This is usually because the lung has not fully re-expanded and has not made contact with the inside of the ribs. When this happens, the fluid can be effectively treated with a different type of drainage tube called an indwelling pleural catheter (IPC) which tunnels under the skin and is drained at home by the district nurses. It is thought that pressure measurements taken from the fluid as it is drained may be able to show doctors whether or not the lung will re-expand before patients are committed to either TP or an IPC. In this research we wish to test if these measurements can be used to choose which is the best first treatment option (TP or IPC) for patients with MPE. We have called this 'EDIT management'. Since it is uncertain whether this new approach will work, patients will be randomised to have either standard treatment or EDIT management. We will compare the two groups to assess whether the patients who had EDIT management had to have fewer repeat procedures over the following 3 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
EDIT management 1. Volumetric Pleural MRI for pre-aspiration pleural cavity volume 2. Large volume pleural aspiration with recording of intra-pleural pressure during aspiration 3. Volumetric Pleural MRI for post-aspiration pleural cavity volume 4. Computation of PEL250, defined as the rolling average of pleural elastance over the preceding 250ml aspirated. MaxPEL250 ≥ 14.5 cm H2O/L: allocated to 1st-line IPC MaxPEL250 \< 14.5 cm H2O/L: allocated to 1st-line TP 5. EDIT-directed 1st-line treatment to be delivered within 24 hours; if insufficient residual pleural fluid to allow standard Seldinger insertion technique then Boutin-type needle used for pneumothorax induction and guide wire insertion.
Intercostal chest drain insertion and talc slurry instillation according to British Thoracic Society guidelines
Queen Elizabeth University Hospital
Glasgow, United Kingdom
RECRUITINGFeasibility of recruiting 30 patients within 12 months and randomising them to either EDIT Management or Standard Care
The number of patients recruited and randomised within 12 months
Time frame: 12 months
Failure rate of the manometry procedure
Defined as the proportion of patients in whom PEL cannot be computed
Time frame: 12 months
Incidence of adverse events associated with the manometry procedure
Number of participants with Adverse Events (AEs) and Serious AEs (SAEs), defined by United Kingdom Good Clinical Practice in Research, associated with use of the digital pleural manometer
Time frame: 12 months
Aspiration threshold to detect abnormal pleural elastance
The pleural fluid aspiration volume at which the rolling average pleural elastance over the preceding 250ml (PEL250) first exceeds the upper limit of normal (14.5cm H2O/L).
Time frame: 12 months
Proportion of patients requiring pneumothorax induction following manometry
The proportion of patients in which pneumothorax induction is required to facilitate safe intercostal chest drain/IPC insertion in the EDIT arm (Group A)
Time frame: 12 months
Assess accuracy of pleural cavity volume change assumptions
To test the assumption that pleural cavity volume change is equivalent to the volume of pleural fluid removed during aspiration by measuring: 1. Pleural fluid aspiration volume 2. Pleural cavity volume change, as measured directly using volumetric Magnetic Resonance Imaging (MRI), calculated as pre- minus post-aspiration pleural cavity volume
Time frame: 12 months
Assess accuracy of ultrasound effusion volume estimate
To test the accuracy of a predictive model of pleural effusion volume based on thoracic ultrasound measurements by measuring: 1. Thoracic ultrasound estimated total pleural effusion volume 2. Pre-pleural fluid aspiration pleural cavity volume measured by volumetric MRI
Time frame: 12 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.