“I think it’s essential that people keep signing up to these type of trials to push research forward.”
A study looking at different types of stent to treat bowel obstruction in people with bowel cancer (CReST2)
This study is for people whose bowel cancer is causing a blockage (bowel obstruction).
More about this trial
Stents are used to treat obstruction in people whose bowel cancer cannot be cured by surgery, or in people who are not fit enough for surgery.
The stent is a metal mesh tube. It pushes back the blockage allowing faeces and wind to pass through the bowel normally.
The mesh tubes are usually uncovered. This trial is comparing standard uncovered stents with covered stents. Both types of stent are made of wire mesh but the covered stents have a fabric coating. This study aims to find out:
- how uncovered and covered stents the affect quality of life of people with bowel cancer
- whether uncovered or covered stents reduce the risk of complications, such as the stent moving, or needing a second stent or surgery
Who can enter
The following bullet points list the entry conditions for this study. Talk to your doctor or the study team if you are unsure about any of these. They will be able to advise you.
You may be able to join this study if you are over 16, and any of the following apply. You:
- have bowel cancer that has not spread and which cannot be cured with surgery
- have bowel cancer that has spread to another part of your body (metastatic) and which cannot be cured with surgery
- are not fit enough for surgery
You cannot join this study if any of these apply. You:
- have or are at risk of bowel perforation (a tear in your bowel wall)
- have cancer in the lower third of your rectum (back passage)
- are being or will be treated with antiangiogenic drugs (such as bevacizumab)
- are pregnant
This is a randomised trial. It will recruit about 350 people from across the UK.
If you decide to take part in this study the type of stent you get will be decided by chance. Neither you nor your doctor will be able to decide which group you are in:
- you have a 1 in 2 (50%) chance of being treated with an uncovered stent
- you have a 1 in 2 (50%) chance of being treated with a covered stent
Quality of life questionnaires
You are asked to complete some questionnaires before your treatment and afterwards. They ask about side effects and how you are feeling. These are called quality of life questionnaires.
You complete questionnaires before your stenting procedure and the following points afterwards:
- 30 days
- 3 months
- 6 months
- 12 months
- 18 months
- 24 months
The quality of life questionnaire may also be sent directly to your home.
Your bowel blockage will have shown on a CT scan, or another test such as a contrast enema.
The stenting procedure happens in the x-ray department or endoscopy suite. You have a drug to make you sleepy (sedative) before the procedure.
Usually you stay in hospital overnight and might go home the next day if your bowels are working normally.
The trial team would like to see how you feel about your life for two years after your stent is placed. This may be when you attend Outpatients appointments.
Depending on the centre you attend, you may have an outpatient appointment 4 weeks after your procedure, and every 3 months for year 1.
Outpatient appointments may be every 6 months in the second year after you have your stent.
You will not need to attend any additional appointments. Questionnaires are posted to your home address if you are not due to attend an outpatient appointment.
Complications of stenting can include:
- the doctor putting the tube in has difficulty placing the stent to clear the blockage, possibly causing a delay in surgery
- a small tear in the bowel (bowel perforation), which may need surgery to repair it
- growth of the cancer into the stent causing another blockage in the bowel
- movement of the stent
- As the stent is put in place using x-rays to see where it is you will get a small radiation dose (similar dose to other treatment x-ray treatments)
How to join a clinical trial
Professor James Hill
Manchester University NHS Foundation Trust
NIHR Health Technology Assessment (HTA) programme
University of Birmingham Clinical Trials Unit