STREAMLINE
Research type
Research Study
Full title
Smarter therapeutic and diagnostic intervention in malignant pleural effusion - a feasibility randomised study
IRAS ID
328727
Contact name
Najib Rahman
Contact email
Sponsor organisation
University of Oxford/Research Goveranance, Ethics and Assurance
Duration of Study in the UK
2 years, 3 months, 1 days
Research summary
A malignant pleural effusion (MPE) is a buildup of fluid around the lungs due to any type of cancer that has either started or spread to the lining of the lungs (pleura). This effects over 100 people per day in the UK and patients with MPE experience debilitating breathlessness due to fluid build up and delays in diagnosis.
In the current investigation and management pathway for patients suspected MPE, patients have some fluid drawn off and analysed for cancer cells, but recent data suggests that this is only adequate for full diagnosis in 20-40% of patients. The patient therefore has to come back for a biopsy of the lining of the lung. Once a diagnosis is secured, a long-term tube in the chest (indwelling pleural catheter, IPC) can be inserted to provide long term fluid control. This can be drained by a district nurse or carer at home. Typically, patients wait 6 weeks for a diagnosis and over 2 months for long term control of breathlessness.
We aim to create a new accelerated pathway for patients suffering with potential MPE, such that at their first visit, patients will be offered a biopsy which give them the highest likelihood (80-95% success rate), of reaching a diagnosis and in the same visit, the patients will have a long term chest tube fitted (IPC) so they are not left breathless and needing multiple procedures.
Our study will randomise patients into either the current standard care pathway, or into the accelerated pathway. We will assess the time to diagnosis, overall duration of breathlessness while awaiting a diagnosis, and quality of life.
Given the more extensive first procedure in the accelerated pathway, a small-scale feasibility study of 40 patients is planned to assess whether patients find this acceptable and this is deliverable within the NHS.
REC name
London - Brighton & Sussex Research Ethics Committee
REC reference
23/LO/0772
Date of REC Opinion
11 Oct 2023
REC opinion
Further Information Favourable Opinion