OPTIMUM Trial
Research type
Research Study
Full title
Randomised controlled trial comparing outpatient management of malignant pleural effusion via an indwelling pleural catheter and talc pleurodesis versus standard inpatient management in improving health related quality of life.
IRAS ID
174522
Contact name
Liju Ahmed
Contact email
Sponsor organisation
Guy's and St Thomas' NHS Foundation Trust
Duration of Study in the UK
1 years, 6 months, 0 days
Research summary
The lung is covered by membrane called the pleura which produces a small amount of fluid as a lubricant between the lungs and the inside of the chest during breathing. Cancers can spread to this membrane stimulating an excess production of fluid. This is called a malignant pleural effusion. Fluid accumulates causing compression of the lung resulting in breathlessness.
This is a common occurrence in terminally ill cancer patients and can result in distressing symptoms and impact on quality of life.
Treatment is aimed at relieving breathlessness and improving quality of life. The standard approach is to drain off the fluid with a chest tube. This temporarily alleviates breathlessness but the fluid will re-accumulate once the drain is removed. To prevent this, talc is inserted into the space through the tube, a technique known as pleurodesis. Talc is an irritant causing the two sides of the space to stick together to stop the fluid returning. Although successful in 80% of cases its main disadvantage is a median hospital stay of 4 days to undergo this treatment. This is precious time that can be spent at home.
Another approach is insertion of small plastic tube called an indwelling pleural catheter under the skin into the fluid space as a day case. The patient is then left with a small tube through which fluid can be drained off on repeated occasions. Patient, their carers or district nurses receive training which allow the fluid to be drained at home providing symptomatic relief. The key advantage of this technique is that it can be managed as an outpatient.
There are no studies primarily comparing quality of life outcomes between these two approaches. This study aims to investigate whether improved health related quality of life can be achieved with an indwelling pleural catheter.
REC name
London - Brighton & Sussex Research Ethics Committee
REC reference
15/LO/1018
Date of REC Opinion
15 Jun 2015
REC opinion
Favourable Opinion