A study looking into screening people who are at risk of Barrett's oesophagus (BEST)

Please note this trial is no longer recruiting patients.

This study is looking into a new screening tool for people with a high risk of developing Barrett’s oesophagus.

In Barrett’s oesophagus, there are changes in the normal cells that line the food pipe (oesophagus or gullet). This is caused by acid coming back up the food pipe from the stomach (acid reflux). Over a long period of time, people with Barrett’s oesophagus can develop ulcers or narrowing of the food pipe (oesophageal stricture). There is also a small increase in risk of oesophageal cancer . People with Barrett’s oesophagus usually have an endoscopy every 2 years to check for these conditions.

There is no easy screening test available at the moment to pick up Barrett’s oesophagus. Doctors are concerned that many people with Barrett’s oesophagus may not be identified. People may be diagnosed with Barrett’s oesophagus as a result of an endoscopy and biopsy (tissue sample). But this is quite an invasive test and doctors do not recommend that it is used routinely.

This study will recruit people aged 50 to 70 years, who have acid indigestion or heartburn. The aims of this study are to find out the acceptability of the screening test and the new tool. And to see how well the screening tool works.

The results of the study may help doctors to improve diagnosis and treatment for people with Barrett’s oesophagus in the future. Please note, you cannot volunteer to take part in this trial. If you are eligible, your doctor may ask you if you would like to join the trial.

Recruitment

Start 01/05/2008

End 17/03/2010

Phase

Pilot

Who can enter

You can enter this trial if you

Are a patient at one of the recruiting GP centres in the UK and are invited to take part
Have taken medication for acid indigestion or heartburn for more than 3 months in the last 5 years
Are between 50 and 70 years old

You cannot enter this trial if you

Have already been diagnosed with Barrett’s oesophagus
Have had an endoscopy within the last year

Trial design

This study will recruit 500 people from the GP surgeries taking part. Your GP will send you a letter inviting you to take part in the study. If you agree, a member of the research team will contact you to arrange to see you at your GP surgery at a time that suits you.

At the appointment, you will see a member of the research team. Firstly, they will ask you to swallow a small tablet. There is a small sponge inside the tablet attached to a piece of string. After you have swallowed the tablet, it takes about 5 minutes for it to dissolve in your stomach. The researcher will spray the back of your throat to numb it. And then gently pull the string to remove the sponge from your stomach. As the sponge is pulled up and out of your mouth, it collects cells from the lining of the food pipe.

The researchers will look at the samples collected on the sponge. After about 3 weeks, they will contact you to let you know your result. If you have a positive result, you may have Barrett’s oesophagus and will be invited to have an endoscopy to check. 1 in 10 people (10%) who have a negative test result will also be invited to have an endoscopy. This is to make sure that people with a negative test result don’t have Barrett’s oesophagus. The researchers can tell you more about this.

The researchers will also take a blood sample. They will store it, and may use it in future studies to look for blood markers that that could help diagnose Barrett’s oesophagus.

You will fill in a questionnaire on the day you have the sponge test. The researcher will send the questionnaire again 1 week and 3 months later, for you to fill in and return. The questionnaire will also ask you how you felt about having the sponge test.

The trial team may ask you to take part in an interview. In the interview, they will ask you what you know about Barrett's oesophagus and how you feel about screening.

Hospital visits

If you are asked to have an endoscopy, you will have it at your local hospital outpatient department. Apart from this and the initial appointment at the GP surgery, you won’t have any other hospital visits as a result of taking part in the study.

Side effects

You may have slight sore throat for 24 hours after the sponge test. There is a possibility of bleeding and the sponge separating from the string, but this is very unlikely to happen. The researcher will keep a close eye on you during the sponge test and treat any problems straight away.