A trial looking at relieving a blockage caused by suspected bowel cancer with a tube inside the bowel (CReST)

This trial is looking at putting an expanding tube (a stent) inside the bowel instead of having emergency surgery when the bowel is blocked. The trial is funded by Cancer Research UK.

Bowel cancer is sometimes diagnosed because it causes a blockage in the bowel, which makes you very unwell. In this situation, you need to have emergency surgery to relieve the blockage and allow your bowel to start working again.

Doctors often treat bowel cancer with surgery. But emergency surgery is more difficult than surgery that is planned. There is a higher risk of complications after surgery and it is more likely that you will need to have a colostomy (a stoma).

In this trial, the researchers want to see if it is possible to put a stent into the bowel to relieve the blockage (endoluminal stenting). The stent opens up the bowel so that the waste from food you have digested can pass through.

If this works, your specialist will then have time to plan the best treatment for you. And you will be able to get a bit better before you have surgery. Most people will go on to have an operation, but depending on the results of the tests you have, your specialist may decide you should not have surgery.

In this trial, the researchers hope to learn more about endoluminal stenting and to see if it

Reduces complications of surgery and the length of time spent in hospital
Helps people to live longer

They also want to find out if having a stent instead of emergency surgery

Means fewer people need to have a stoma following a bowel blockage
Improves quality of life

Recruitment

Start 01/03/2009

End 31/08/2013

Phase

Phase 3

Who can enter

You can enter this trial if you

Have a blockage in the left side of your bowel that needs emergency treatment and that scans or X-rays show is most likely to be caused by bowel cancer
Are well enough to have surgery

You cannot enter this trial if you

Have signs of an infection in your abdomen (peritonitis) or signs that there is already a hole in your bowel (perforation)
Have a blockage in the lowest part of your bowel (the rectum) and you need to have another type of treatment before surgery

Trial design

The trial will recruit about 400 people. It is a randomised trial. The people taking part will be put into one of 2 treatment groups by a computer. Neither you, nor your doctor, will be able to decide which group you are in.

If you are in group A, you will have a stent put in. You have some sedation to help you relax. It will probably make you sleepy. You lie on your left side. While watching on an X-ray, the doctor passes a wire or a flexible telescope into your bowel to find the blockage. This allows them to move the stent into the right place. Once in place, the stent expands to open up the bowel. When this happens, you may suddenly pass some wind and a liquid bowel motion.

Your specialist will then be able to plan the best treatment for you, which will probably include planned (elective) surgery.

If the surgeon is not able to place the stent successfully for some reason, you will still need to have emergency surgery to remove the blockage. And there is a risk that putting in a stent can make a hole in the bowel. If this happens, you would also need to have emergency surgery.

If you are in group B, you will have emergency surgery to remove the blockage in your bowel. The surgeon will remove the blockage and the part of the bowel surrounding it. They may be able to join the 2 ends of the bowel back together (an anastomosis). Or they might need to form a colostomy. This may be temporary until your bowel heals, or it may be permanent.

Hospital visits

If you are asked to take part in this trial, you will already be in hospital. If you have a blockage in the bowel, you will be quite unwell and need to have treatment very quickly. But before you have treatment, you will have some tests. These include

Blood tests
X-rays
CT scan, barium enema or colonoscopy

If you are in group A, you may be able to go home the day after you have the stent put in, as long as you are opening your bowels normally. You will have any further tests you need as an outpatient.

If you are in group B, you will stay in hospital for longer to get over the operation.

Everybody taking part will have follow up appointments with the trial team

6 weeks after you go home from hospital, then
Every 3 months for a year
Every 6 months for the next 2 years

Side effects

There are risks associated with stenting and with emergency surgery to relieve a blocked bowel.

It is possible that the specialist may not be able to put a stent in. If this happens, you will still need to have emergency surgery. And there is a risk of getting a hole in your bowel during the stenting procedure, which would also mean you need to have emergency surgery.

It is possible that the stent can move. It his happens, it is usually passed out of your body with a bowel motion and does not hurt. The stent can be replaced if the bowel gets blocked again.

In theory, it is also possible that putting in a stent could increase the risk of the cancer spreading elsewhere in the body.

There are some problems that may occur after any type of surgery. But if you have emergency surgery, there is a higher risk of complications, including heart and lung problems.