This trial aims to offer the Cytosponge test, a less invasive way to test for changing oesophageal cells in patients with acid reflux symptoms, to up to 150 GP practices.
The researchers hope to assess whether the Cytosponge test will increase the number of Barrett’s oesophagus diagnoses in primary care. They will also examine how cost effective the technique is and whether patients are prepared to take the test.
This is the last step required before it could be adopted into mainstream practice. The technique could streamline the patients referred for an endoscopy to those that need it.
The trial researchers are looking for GP surgeries across the UK to sign up and take part. The criteria for the trial mean that participants must be aged 50 and over and be on long-term acid-suppressant medication.
The team aim to recruit nearly 9,000 patients to the trial. Half will receive the standard of care while the other half will be offered the Cytosponge test as well. Patients with a positive Cytosponge test result will also receive the standard endoscopy later to confirm the results of the Cytosponge test. At the end of the trial, 10 per cent of patients on both arms of the trial will be offered an endoscopy.
In the Cytosponge test, the patient swallows a capsule with a sponge inside, attached to a string. When it reaches the stomach, the capsule dissolves, exposing the sponge, which a nurse then pulls out. As it passes up the oesophagus, it collects cells from the lining for analysis. It can be uncomfortable but it’s not painful and the test takes 5 minutes to perform.
While most patients diagnosed with Barrett’s oesophagus won’t develop oesophageal cancer, understanding who is at increased risk could help to prevent oesophageal cancer, or diagnose the disease earlier when treatment is more likely to be successful.
Professor Rebecca Fitzgerald, lead author at the MRC Cancer Unit, University of Cambridge, said: “We’re excited to see this being tried out in GP surgeries. It’s a safe way to test for Barrett’s oesophagus and we hope that this will make it easier for GPs to identify patients who have an increased risk of developing oesophageal cancer without having to refer them to hospital.”
Dr Richard Roope, Cancer Research UK’s GP expert, said: “GPs are always looking for new ways to ensure patients receive the best possible care. Trialling a new, less invasive technique to test for Barrett’s oesophagus means that many patients each year could be saved from experiencing an endoscopy which can be uncomfortable. Around three in every 100 people with Barrett’s oesophagus go on to develop oesophageal cancer so techniques that help us to prevent or diagnose the disease earlier are vital.”
The researchers plan to open the trial in Eastern, North East and North Cumbria, East Midlands and Yorkshire and Humber. Other regions may come on board depending on the local commissioning arrangements.
* BEST3 clinical trial
The Cytosponge – a ‘pill on a string’ – was developed by researchers at the MRC Cancer Unit of the University of Cambridge. Early trials in patients were conducted at the Clinical Investigation Ward of the NIHR Cambridge Clinical Research Facility on the Cambridge Biomedical Campus.
The clinical trial design was led by the Barts Clinical Trials Unit at the Wolfson Institute of Preventive Medicine, Queen Mary University of London with collaborators from the universities of Durham and Leeds, and University College London. The trial is supported by the NIHR Clinical Research Network nursing teams.