
“I think it’s really important that people keep signing up to these type of trials to push research forward.”
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This study is testing how practical it would be to run a large trial comparing traditional surgery with keyhole surgery or a combination of the two, to treat cancer of the food pipe.
If you have cancer of the food pipe found at an early stage, you may have surgery, or surgery with chemotherapy. Surgery to treat cancer of the food pipe is a major operation as it usually involves removing some of the food pipe and using the stomach to replace it.
There are now 3 ways of carrying out this operation. Each aims to cure food pipe cancer, but we don’t yet know which is the best.
Researchers in this study want to compare the 3 types of surgery in a large trial. But before they can do this they need to test it on a small scale, to work out how practical it would be to recruit lots of people later on. So this pilot study will recruit and treat people with cancer of the foodpipe from hospitals in Bristol and Plymouth.
The aim of the main trial is to compare how well each type of surgery works in terms of recovery, health related , cost and how long people live after surgery. The aim of this pilot study is to test how well the larger trial is likely to work, by trying it out in 2 hospitals to start with.
If you are suitable for this study, your specialist will ask if you would like to take part. People taking part will
You cannot enter this study if you
This study will recruit 36 people. It is randomised. The people taking part will be put into different groups by a computer.
If you are a patient taking part in Plymouth, you will be put into one of 2 groups by a computer. If you are a patient in Bristol you will be put into one of 3 groups by a computer. Each group has a different type of surgery to treat their cancer of the food pipe. Neither you nor your doctor will be able to decide which group you are in. All of the surgery in the study is . Whichever group you are in, your surgery will take place in the same way as it would if you were not in the study.
If you are in group 1, you will have traditional ‘open’ surgery. Open surgery is where the surgeon makes 2 cuts in your chest and tummy (abdomen).
If you are in group 2, you will have a combination of open surgery and keyhole surgery. The surgeon will make up to 5 small cuts in your tummy and a cut in your chest.
If you are in group 3 you have keyhole surgery (this is open to Bristol patients only). With this surgery you have small cuts in your tummy and chest.
The team will audio and video record your surgery. This will help them to check that all the operations were done in a similar way. They will also audio record any appointments where the study is discussed.
You fill out a questionnaire before your surgery and then 2 days, 6 days, 6 weeks, 3 months, 6 months and 12 months after your surgery. The questionnaire will ask about side effects and how you’ve been feeling. This is called a quality of life study. The team may also ask to interview you about your experiences of the study.
Whichever group you are in, you are likely to stay in hospital for between 8 and 14 days. You will be contacted by the study team about 9 times in the 3 years after your surgery, so they can see how you are getting on.
The team will pay travel expenses for any hospital visits that you make just for the study.
There should be no extra risk to you during this study because all 3 operations are standard procedures.
About 4 in 10 people (40%) have a complication with each of the operations. This can lead to a longer hospital stay or the need for a second operation. The study team will talk through these risks with you.
If you feel distressed in the interview about your experiences, you will be able to stop at any time.
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Dr Chris Metcalfe
Professor Jane Blazeby
Clinical Trials and Evaluation Unit Bristol and Bristol Randomised Trials Collaboration
NIHR Health Technology Assessment (HTA) programme
National Institute for Health Research Cancer Research Network (NCRN)
University of Bristol
Freephone 0808 800 4040
“I think it’s really important that people keep signing up to these type of trials to push research forward.”