Pre-EDIT
Research type
Research Study
Full title
Pre-EDIT: A randomised, feasibility trial of Elastance-Directed Intra-pleural catheter or Talc Pleurodesis (EDIT) in the management of symptomatic Malignant Pleural Effusion without obvious non-expansile lung
IRAS ID
223276
Contact name
Joanne McGarry
Contact email
Sponsor organisation
NHS Greater Glasgow & Clyde
Duration of Study in the UK
0 years, 10 months, 1 days
Research summary
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.
REC name
West of Scotland REC 3
REC reference
17/WS/0042
Date of REC Opinion
8 Mar 2017
REC opinion
Further Information Favourable Opinion