The efficacy of Indwelling Pleural Catheter placement versus IPC placement PLUS sclerosant (talc) in patients with malignant pleural effusions managed exclusively as out-patients

Plain English Summary

Background and study aims
Many people with cancer develop a build-up of fluid in the space between the lung and the chest wall, known as the pleural space. This may be due to a tumour which directly affects the lung lining (the pleura) or another cancer from elsewhere which spreads to affect the pleura. If enough fluid accumulates the lung can be compressed, making patients feel breathless. This fluid is called a malignant pleural effusion. The traditional method for dealing with this fluid is to admit the patient to hospital and insert a chest tube into the space around the lung where the fluid has built up, which allows the fluid to be drained away, improving symptoms. However, this fluid may build up again after the tube is removed. This usually takes some time but can occur in only a few days. In order to try and prevent this, an irritant substance such as talc powder can be inserted through the chest tube. This aims to cause the two sides of the pleural space to stick together which prevents further fluid build-up, and is called pleurodesis. Whilst often relatively successful, this method of pleurodesis can be inconvenient for patients as they often need to be in hospital for at least 5 days. In recent years an alternative method has become available. This involves the insertion of a chest tube which is tunnelled under the skin, and hence can stay in place for much longer. Their main benefit is that they can be inserted as an outpatient and as more fluid builds up it can be tapped off using the drain as needed by community nurses. In the United States, these indwelling pleural catheters (IPC) are often the first line of treatment for malignant pleural effusions. Another benefit is that if left long enough, these tubes can also cause the pleural surfaces to adhere to each other and so may actually prevent further fluid build-up in much the same way as talc can. The rate of pleurodesis, however, is not as high as with talc, and if used for more than a few weeks the cost of using the IPC begins to exceed that of traditional treatment. This study aims to find out the best way of treating patients with malignant pleural effusions by treating people with a combination of both indwelling pleural catheter and talc instillation. We shall measure the rates of pleurodesis after five weeks compared with patients treated with just a pleural catheter alone. In theory, the addition of talc should allow the catheters to be removed more quickly. Although this study will look at patients from the UK, the results will be applicable globally and may help to change the way in which malignant pleural effusions are managed.

Who can participate?
Adult patients with a malignant pleural effusion that is suitable for insertion of an indwelling pleural catheter.

What does the study involve?
All participants receive an IPC as per normal practice, which is drained at least twice per week. After 10 days a chest x-ray is performed to ensure that the lung has fully expanded and the fluid has been drained away. If this is the case, patients are randomly allocated to receive either a mixture containing talc powder or a placebo (an inert/dummy substance) through their IPC. Patients are then followed up for 10 weeks at 2-weekly intervals, with IPC drainage continuing. At each appointment, patients will have a chest x-ray, an ultrasound scan of the chest, and will be asked to fill out questionnaires about their quality of life. For the duration of the study, patients are asked to keep a record of how much pain and breathlessness they are feeling using a chart. Participants are also asked to provide samples of blood and pleural fluid during the trial, although they can opt out of this if they choose.

What are the possible benefits and risks of participating?
All patients should experience the benefits of having an indwelling pleural catheter in place, so that breathlessness can be relieved quickly and easily. IPCs can lead to short-term soreness around the insertion site, although this is easily managed with painkillers. Talc is a safe and widely-used substance. Some patients may experience a small amount of pain and/or a fever after administration but this may also be controlled with simple painkillers. We do not expect any extra risks from the combination of the two treatments, but we do hope that those who receive talc will have the benefit of quicker, more successful pleurodesis.

Where is the study run from?
18 NHS hospitals in England, with the main centre being Southmead Hospital in North Bristol

When is the study starting and how long is it expected to run for?
June 2012 to March 2016

Who is funding the study?
CareFusion (USA)

Who is the main contact?
Dr Nick Maskell
nick.maskell@bristol.ac.uk

https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-trial-comparing-2-ways-treating-build-up-of-fluid-around-lung-ipc-plus

Contact information

Study information

Eligibility

Locations

Countries of recruitment

• England
• United Kingdom

Study participating centres

Sponsor information

North Bristol NHS Trust (UK)
Hospital/treatment centre

Trust Headquarters
Beckspool Road
Frenchay
Bristol
B16 1JE
England
United Kingdom

Website	http://www.nbt.nhs.uk/
"ROR"	https://ror.org/036x6gt55

Funders

Funder type

Industry

Results and Publications

Study outputs

Editorial Notes

25/10/2022: Cancer Research UK plain English results link and total final enrolment added.
11/12/2018: Publication reference added.
19/01/2015: The following changes were made to the trial record:
1. The overall trial start date was changed from 01/08/2012 to 26/06/2012.
2. The overall trial end date was changed from 01/10/2014 to 01/05/2015.
23/07/2015: The overall trial end date was changed from 01/05/2015 to 31/03/2016.