A study looking at different types of stent to treat bowel obstruction in people with bowel cancer (CReST2)

Please note - this trial is no longer recruiting patients. We hope to add results when they are available.

Cancer type:

Bowel (colorectal) cancer

Status:

Closed

Phase:

Phase 3

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.

CREST 2 trial stent diagram 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

Trial design

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.

Hospital visits

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.

Follow up
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.

Side effects

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)