Linacre Trial 2020
A feasibility study for the comparison of standard medical therapy against anti-reflux surgery for the long-term management of Barrett’s Oesophagus.
Barrett’s Oesophagus (changes in the cell lining) occurs in approximately 20% of people with reflux. This condition increases the risk of oesophageal cancer. To try and prevent cancerous changes, patients with Barrett’s Oesophagus are prescribed long-term high dose acid suppression and anti-inflammatory medication. The medication and regular assessments cause a high level of anxiety for the patients and are only partially effective.
Prevention of reflux would be alternative strategy to treat this condition. Until recently, there has not been a safe long-term procedure to achieve this. The LINX device has now been in use for 10 years and it has been proven to be effective in reflux prevention. The device is placed (by keyhole surgery) around the bottom of the oesophagus to provide a barrier against reflux. This procedure has the potential to reduce medication use and its side effects. The device will also prevent reflux symptoms and inflammation of the oesophagus, reducing the risk of early cancer changes.
HOW WILL THE STUDY WORK?
The trial will initially recruit fifty patients and randomise them by chance to one of two groups. The first group of twenty-five patients will continue on medical therapy and regular surveillance. The second group will receive the LINX device with the same surveillance and follow up. Both groups of patients will be required to be available for follow up appointments, either in person or by telephone/email and to complete questionnaires. If the study shows promising results, then it will be extended and expanded to include a larger number of patients with Barrett’s Oesophagus. The long-term aim will be to see if this is an acceptable and effective way of treating patients, whilst reducing the risk of oesophageal cancer.
WHAT DOES THE STUDY HOPE TO ACHIEVE?
It is hoped that the LINX device may provide an alternative strategy in the management of Barrett’s Oesophagus that is more acceptable to patients.
WHY HAVE I BEEN INVITED?
Anybody with Barrett’s Disease of the oesophagus will be given the opportunity to take part. The study will be promoted through awareness groups and at the centres supporting Barrett’s surveillance.
DO I HAVE TO TAKE PART?
You are under no obligation to take part in the trial. The trial results will be published and made available through patient awareness groups in order to help other people with the condition. Any involvement is voluntary and will be treated in confidence. Trial participants will not be identifiable from the published data.
You will be invited to attend an initial assessment for the trial. Once you have agreed to participate, you will be invited to attend for tests to assess your suitability for the trial. The tests include an analysis of your Oesophagus. This measures how much reflux you are having and how your Oesophagus performs when you swallow. To do this, a narrow tube is placed from the nose into the oesophagus for 24 hours. This will remain in situ whilst you go about your normal daily activities. The examination gives important information for the trial and also determines if your oesophageal function is suitable for the trial. You will then be randomised to either continuing the medical treatment or receiving the LINX device. The ‘oesophageal physiology test’ will then be repeated at 6 months to see which treatment is most successful in preventing reflux. The routine surveillance endoscopy will be carried out at one year to check the Barrett’s area and to see if there has been any improvement.
Questionnaires will be used at each stage to assess reflux, anxiety and tolerability of both treatments.
WHAT ARE THE BENEFITS OF TAKING PART?
There is no guarantee of any specific treatment benefits in either group. The LINX device is not currently offered as a treatment for Barrett’s Oesophagus, so would only be available through participation in this trial. The trial will broaden the knowledge on the treatment options and natural history of Barrett’s Oesophagus, which will be a benefit to other people with the same condition.
WHAT ARE THE DISADVANTAGES OF TAKING PART?
The questionnaires will take time to complete. If you are not randomised to the LINX procedure you will continue on the same treatment you would have been recommended if you had not participated. If the trial supports the use of the LINX device in the management of Barrett’s Oesophagus, it may be possible to be treated with this after the trail period ends.
The LINX device is used regularly to prevent gastro-oesophageal reflux. We know that it carries the risk of some side effects. As the device tightens the sphincter at the lower end of the oesophagus, it can carry a risk of swallowing problems, especially during the initial period. Patients will not be able to have an MRI scan (over 3T). There is a small risk of device erosion or removal.
EXPENSES AND PAYMENTS
There will be no additional expenses or payments for participating in the study.
WHAT HAPPENS WHEN THE RESEARCH STUDY STOPS?
This is a feasibility trial with a follow up period of 18 months. If the trial is successful, the study would be extended and offered to other patients with Barrett’s Oesophagus. When the trial ends, participants will continue with their surveillance at their local hospital.
WHAT IF THERE IS A PROBLEM?
Your local recruiting hospital will provide contact numbers in case there are any concerns or problems during the course of the trial. Both treatments are already available.
WHAT WILL HAPPEN IF I DON’T WANT TO CARRY ON WITH THE STUDY?
You are able to leave the study at any point and continue surveillance at your local hospital. If you have had the LINX device, you can see the surgeon to discuss options. Removal is possible if required.