Introduction
Endoscopy services in many healthcare systems face increasing demand, and novel approaches to patient triage are needed. Recent research suggests that capsule sponge testing combined with immunohistochemical biomarkers can prioritise patients with Barrett’s oesophagus (BO) and gastro-oesophageal reflux for oesophagogastroduodenoscopy (OGD).1,2 However, it is not yet widely integrated into clinical practice globally. The capsule sponge is not currently used in South Wales and Northern Ireland, and further investigation into its implementation in these regions is required.
Aims & Methods
This multicentre feasibility study aimed to evaluate whether the capsule sponge could be used in Wales and Northern Ireland to triage patients with gastro-oesophageal reflux or BO for OGD, and to assess feedback from patients and staff. Patients referred to gastroenterology due to gastro-oesophageal reflux and patients with known BO under surveillance were eligible. Patients were recruited from 3 hospital sites in Wales and 2 in Northern Ireland, undergoing the test in nurse-led clinics between December 2024 and March 2025. Pathology samples were processed centrally in an accredited laboratory (Cyted), examining for TFF3 (suggestive of intestinal metaplasia), p53 and atypia (high-risk findings associated with dysplasia). Patient feedback was collected at the clinics, and feedback forms were also sent to patients and staff.
Results
201 patients were recruited, with 196 (97.5%) completing the capsule sponge test: 116 with BO (median age 59, 84% male) and 80 with reflux (median age 49, 56% female). 101 BO samples (87%) were adequate for analysis. Of these, 21 (21%) were positive/equivocal for atypia/p53 and deemed high-risk, and 80 (79%) were negative for both atypia and p53. High-risk patients were prioritised for urgent OGD, with the remainder followed-up as per the British Society of Gastroenterology guidelines. 61 samples (76%) from patients with reflux were adequate for analysis. Of these, 3 (5%) were positive/equivocal for atypia/p53 and prioritised for urgent OGD, 11 (18%) were TFF3 positive but negative for both atypia and p53 and were booked for routine OGD, and 47 (77%) were negative for all 3 biomarkers and were managed as per usual local practice.
148 patients (76%) who completed a capsule sponge test had previously had an OGD, with 78% of these preferring the capsule sponge, 4% preferring the OGD and 9% being unsure. Feedback forms were completed by 52 patients, with response rates varying by question. 92% rated the capsule sponge procedure good/very good, 3% fair and 5% poor/very poor. When asked how likely they would be to recommend the test, on a scale from 1 (least likely) to 10, patients with reflux gave a mean score of 8.7 and patients with BO 9.6. For whether they would be willing to have the test done again, 83% said yes, 14% not sure and 3% no. Patients’ free text comments indicated they found the capsule sponge to be quicker and easier than an OGD, however some experienced discomfort on sponge withdrawal. 14 staff completed feedback forms. 100% agreed the capsule sponge test was easy to deliver, and 100% rated the implementation of the test pathway as good/very good.
Conclusion
This feasibility study showed that the capsule sponge could successfully triage patients under BO surveillance or with reflux for OGD in Wales and Northern Ireland, with positive feedback from patients and staff. These findings support future integration of the capsule sponge into clinical pathways in these regions, with potential transferability to other healthcare systems internationally.
References
1. Chien S, Glen P, Penman I, Cruickshank N, Bryce G, Crumley A, et al. Oesophageal cell collection device and biomarker testing to identify high-risk Barrett’s patients requiring endoscopic investigation. Br J Surg. 2024 May 13;111(5):znae117.
2. Chien S, Glen P, Bryce G, Cruickshank N, Penman I, Robertson K, et al. Clinical application of capsule sponge testing in symptomatic reflux disease: a national prospective cohort study. BMC Gastroenterol. 2024 Nov 26;24:431.
Disclosure
R McNally, B Afinowi, I Aldred and R Hardwick are employed by Cyted Health, who manufacture the capsule sponge device used in this study. The remaining authors have nothing to disclose.