Explore the vast range of titles available.

IntroductionEndoscopic surveillance is the standard of care for Barrett’s oesophagus (BO), but its effectiveness is inconsistent and operator-dependent. Pan-oesophageal cell collection devices with biomarkers provide patients with a less operator-dependent, cost-effective alternative. We previously developed a risk stratification score for capsule-sponge surveillance.1 Here, we prospectively evaluated this risk stratification tool in patients undergoing capsule-sponge triage to determine the timing of follow-up endoscopy. The aim of the study is to is to prospectively evaluate the accuracy of the risk stratification tool in patients undergoing capsule-sponge triage for BO surveillance.MethodsPatients were recruited from ten hospitals (DELTA study ISRCTN91655550, 2020-2022, and NHS England implementation study 2022–2024). We included patients with a history of BO who had capsule sponge and endoscopy follow-up with biopsies. All capsule sponge samples were processed centrally in an accredited laboratory (Cyted Medical), with positive biomarker results (p53, atypia) independently reviewed by two pathologists. Patients were assigned into one of three risk groups: low (clinical and sponge biomarkers negative), moderate (positive clinical biomarkers - age, sex and segment length), and high risk (positive sponge biomarkers- p53, atypia and atypia of uncertain significance (AUS)) (table 1, legend). Endoscopic follow-up intervals were guided by the risk result at a time interval directed by the clinician. The overall prevalence of dysplasia in the cohort and the prevalence of dysplasia for each risk category were calculated.Abstract O55 Table 1Demographics and histologic outcomes by capsule-sponge risk stratification categoryResults796 patients were included of which 415 (52.1%) were low, 253 (31.8%) moderate, and 128 (16.1%) were high-risk (table 1). Among the low-risk category, the prevalence of HGD, and any dysplasia was 0.7% (3/415), and 2.9% (12/415), respectively. No intramucosal or invasive OAC (≥T2) were detected in the low- or moderate-risk groups. The high-risk group was 4-fold enriched for any dysplasia: 38.3% (49/128) compared with the overall dysplasia detection rate of 9.8% (78/796). When both p53 and atypia were positive, 80.8% (21/26) had dysplasia, compared to single biomarker positivity of 44.4% (4/9) for p53 alone, and 66.7% (2/3) when atypia alone was positive. Among those with AUS, often linked to inflammation, 17.9% (4/67) had dysplasia.ConclusionThis large prospective study has shown that this risk stratification panel can accurately risk stratify patients undergoing BO surveillance with the low-risk group having <1% risk of HGD with no cases of missed OAC. This suggests that sponge-only surveillance is safe in low-risk patients, while positive high-risk biomarkers can successfully enrich for dysplasia and help direct resources towards patients at higher risk.ReferencePilonis ND, Killcoyne S, Tan WK, et al. Use of a cytosponge biomarker panel to prioritise endoscopic barrett’s oesophagus surveillance: a cross-sectional study followed by a real-world prospective pilot. The Lancet Oncology 2022.

Endoscopic surveillance is the clinical standard for Barrett's oesophagus, but its effectiveness is inconsistent. We have developed a test comprising a pan-oesophageal cell collection device coupled with biomarkers to stratify patients into three risk groups. We aimed to prospectively evaluate the prespecified risk stratification tool to establish whether it can identify those at highest risk of dysplasia or cancer to prioritise the timing of endoscopy; and safely be used to follow up the low-risk group, thus sparing patients from unnecessary endoscopies. Participants were recruited as part of two multicentre, prospective, pragmatic implementation studies from 13 hospitals in the UK. Patients with non-dysplastic Barrett's oesophagus had a capsule-sponge test which was assessed in an ISO-accredited laboratory. Patients were included if they were aged at least 18 years with a non-dysplastic Barrett's oesophagus diagnosis at their last endoscopy who were undergoing surveillance according to the published UK guidelines. Patients were assigned as low (clinical and capsule-sponge biomarkers negative), moderate (negative for capsule-sponge biomarkers, positive clinical biomarkers—age, sex, and segment length), or high risk (p53 abnormality or glandular atypia regardless of clinical biomarkers, or both). The primary outcome was a diagnosis of high-grade dysplasia or cancer necessitating treatment, according to the risk group assignment. 910 patients recruited between August, 2020, and December, 2024 participated, of whom 138 (15%) were classified as high risk, 283 (31%) moderate risk and 489 (54%) low risk. The positive predictive value for any dysplasia or worse in the high-risk group was 37·7% (95% CI 29·7–46·4). Patients with both atypia and aberrant p53 had the highest risk of high-grade dysplasia or cancer (relative risk 135·8 [95% CI 32·7–564·0] relative to the low-risk group). The prevalence of high-grade dysplasia or cancer in the low-risk group was 0·4% (95% CI 0·1–1·6); the negative predictive value for any dysplasia or cancer was 97·8% (95% CI 95·9–98·8). Applying a machine learning algorithm as part of a digital-pathology workflow reduces the proportion needing p53 pathology review to 32% without missing any positive cases. The risk-panel substantially enriches for dysplasia and capsule-sponge-based surveillance could be used in low-risk Barrett's oesophagus in lieu of endoscopy. Innovate UK, Cancer Research UK, National Health Service England Cancer Alliance.