Feasibility of primary care-based early detection of Barrett’s oesophagus and oesophageal adenocarcinoma in patients with reflux using capsule sponge testing: real-world insights from the CYTOPRIME 2 Study

Abstract

Objectives: Oesophageal adenocarcinoma (OAC) has a poor prognosis as patients typically present with late-stage disease. Gastro-oesophageal reflux disease (GORD) can lead to Barrett’s oesophagus (BO), the only known precursor to OAC. Detecting patients with BO allows interventions to prevent development of late-stage OAC and improve survival. Non-endoscopic devices, such as EndoSign, coupled with biomarkers trefoil factor 3, atypia and p53 have demonstrated performance for diagnosis of BO. The CYTOPRIME 2 Study was designed to assess the feasibility of implementing this test in a real-world community care setting. Methods: Patients with chronic GORD identified from general practitioner electronic records were invited to have a capsule sponge test (ie, EndoSign) in the community, of which 1815 completed the test. Results: 266 (14.7%) had a subsequent endoscopy based on a positive test. 97 patients (5.3%) of the total group, or 36% of those endoscoped, had BO confirmed at endoscopy of whom 90 (93%) had intestinal metaplasia on histology and 3 had low-grade dysplasia (3%). In addition, 6 patients (0.3%), or 2.2% of those endoscoped, had cancer—4 with OAC, 1 squamous cell oesophageal tumour and 1 early stage gastric cancer. Patients’ and clinicians’ acceptability of the test was high. Conclusions: Non-endoscopic capsule sponge testing can be used successfully in community settings to diagnose BO and minimally symptomatic oesophagogastric cancer in a target population of patients with GORD. Patients diagnosed with BO can be offered prospective surveillance to detect precancerous changes and allow endoscopic therapies to prevent late-stage oesophageal cancer.