A trial looking at how often to monitor people with Barrett's oesophagus (BOSS study)

Please note this trial is no longer recruiting patients.

This trial is to find out if it is better to monitor people with Barrett’s oesophagus every 2 years or to wait until they have a change in their symptoms.

Barrett's oesophagus is a condition where the cells in the lining of the food pipe (oesophagus) change and become abnormal. People with Barrett's oesophagus have a small increased risk of developing oesophageal cancer.

People with Barrett's oesophagus may have regular tests called endoscopies to check if the abnormal cells have become more severe or cancerous. This is called surveillance.

It is not clear yet whether surveillance picks up oesophageal cancer at an earlier stage. Some doctors think that these regular checks may not be necessary and it may be better for people to have an endoscopy only if they need it.

Having an endoscopy can cause anxiety and for a small number of people it may cause short term side effects, such as discomfort, pain or breathing problems. So it is important that people do not have tests they do not need.

The aim of this trial is to see if it is better for people with Barrett’s oesophagus to have an endoscopy every 2 years or to wait until their symptoms get worse.

Recruitment

Start 01/03/2009

End 14/11/2011

Phase

Phase 3

Who can enter

You can enter this trial if you

Have Barrett’s oesophagus which is 1cm or more from where your stomach joins the food pipe (the gastro-oesophageal junction)
Are at least 18 years old

You cannot enter this trial if you

Have severe cell changes (high grade dysplasia) in the lining of your oesophagus
Have been diagnosed with oesophageal cancer
Have a medical condition which means you cannot have an endoscopy, such as severe breathing or heart problems
Live outside the UK

Trial design

This is a randomised trial. 3,400 people will be recruited into 2 groups. The people taking part are put into 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 1, you will have an endoscopy and samples of tissue taken (biopsies) every 2 years. If you are in group 2, you will only have an endoscopy if you have symptoms.

Your doctor will ask you to fill out a quality of life questionnaire and will ask about any medication you are taking. You fill out a questionnaire before you start the trial, and then every 2 years for about 10 years.

If you develop symptoms at any time, you will have an urgent endoscopy, no matter which group you are in.

Hospital visits

If you are in group 1, you go to the outpatient department in your hospital every 2 years for an endoscopy. You fill out your questionnaire at the same time.

If you are in group 2, you only need to go to the hospital for an endoscopy if you start having symptoms. You will be sent questionnaires every 2 years to fill in at home.

For this trial, your doctor will follow your progress for 10 years.