ABSTRACT
Introduction In recent years, endoscopy services throughout NHS Scotland were under substantial strain due to supply/ demand mismatch: these pressures were significantly exacerbated by the COVID-19 pandemic, which saw cessation of all routine and surveillance endoscopies. Cytosponge is a nonendoscopic diagnostic tool demonstrating good specificity and sensitivity for detection of Barrett's oesophagus and dysplasia in the trial setting. Cytosponge was introduced as a triage tool in a real world pilot across NHS Scotland in 2020 under closely audited conditions in response to the COVID-19 pandemic. This presents the initial results of this audit. Methods A national Cytosponge group was formed with representatives from all Scottish health boards and the Scottish government. The two indications for Cytosponge were: Barrett's oesophagus surveillance patients;and new referrals with reflux-predominant symptoms. Cytosponge was introduced in the secondary care setting following appropriate nurse training, with data collected from September 2020 to January 2022. Indications and cytology codes were obtained from Cyted Labs. Results During the study period, Cyted Labs received 3180 specimens from NHS Scotland;3020 of these were formally reported. Indication for Cytosponge was Barrett's surveillance in 2271 samples (75.2%) and reflux symptoms in 749 samples (24.8%). Within the Barrett's oesophagus cohort, 143 samples (6.3%) did not provide adequate cells for analysis. of the remaining 2128 patients, 246 samples (11.6%) demonstrated cellular atypia or aberrant p53 expression and 1425 samples (67.0%) showed simple Barrett's oesophagus. of interest, 457 samples (21.5%) in the Barrett's surveillance group did not demonstrate intestinal metaplasia. Full results for patients with reflux-predominant symptoms were available in 679 samples;70 samples (9.3%) did not yield adequate cells for cytology. Intestinal metaplasia was identified in 83 samples (12.2%), with an additional 23 specimens (3.4%) demonstrating atypia or aberrant p53 expression. Conclusions Cytosponge is a useful diagnostic tool to demonstrate pathology in cohorts of patients unable to access endoscopy during the COVID-19 pandemic due to service pressures. Our initial results give an indication of endoscopy resources required to support Cytosponge;with only 11.6% of Barrett's oesophagus surveillance patients and 15.6% of reflux patients requiring endoscopy to exclude adenocarcinoma or precursor lesions. This significantly reduces the burden on endoscopy services. The study does not describe patients undergoing endoscopy for reflux with other pathologies. However, early results suggest that Cytosponge, combined with nurse-led clinical assessment, is beneficial in these patient pathways.
ABSTRACT
Introduction The CytospongeTM test is a non-endoscopic method to collect cells from the oesophagus and test for biomarkers of early oesophageal cancer and its precancerous form, Barrett's oesophagus. The real-world implementation pilots of the Cytosponge has been accelerated in response to the COVID-19 pandemic. At the onset of the pandemic, when endoscopy services were paused, guidelines from the British Society of Gastroenterology were updated to recommend the use of alternatives including the Cytosponge. In December 2020, NICE published a Medtech Innovation Briefing for use of the Cytosponge test as a triage tool for endoscopy to identify people at risk of oesophageal cancer. Aims & methods Implementation pilots were launched within the NHS in England and Scotland, as well as the Innovate UK-funded research project, Project DELTA. The Cytosponge test was offered to two patient cohorts as an alternative to endoscopy: (1) patients already diagnosed with Barrett's Oesophagus, and so in need of routine surveillance;and (2) patients referred from primary care with reflux symptoms. Samples were received, processed and analysed at the ISO 15189:2012 accredited laboratory at Cyted. Pathology reports were issued with TFF3, p53 and atypia biomarker results and clinical recommendations. Any reports positive for p53/atypia biomarkers were double reported. Here, we evaluate the real-world laboratory metrics for the Cytosponge test in secondary care. Results Between August 2020 and November 2021, Cytosponge tests were delivered to 5373 patients at 48 hospitals across England and Scotland. For 4842 diagnostic reports issued by mid-November, 2807 patients had Barrett's Oesophagus and 2034 reflux symptoms. For Barrett's surveillance, 2629 (93.7%) of patient samples had sufficient cellular material for analysis, including sampling the gastric cardia. Of these 324 (12.3%) exhibited cellular atypia (including uncertain significance), dysplasia, or aberrant p53 expression. These patients were recommended to have an endoscopy. Patients without evidence of atypia/dysplasia/p53 were recommended surveillance by Cytosponge or endoscopy after the recommended interval by clinical guidelines. In the symptomatic reflux cohort, 1854 (91.2%) patient samples had sufficient cellular material for analysis, including sampling the gastric cardia. Of these 185 (10.0%) exhibited intestinal metaplasia corroborated by TFF3 expression and a further 44 (2.4%) exhibited atypia/ dysplasia/p53. These patients were recommended to have an endoscopy. Otherwise, patients were recommended management according to symptoms. Discussion A high-quality centralised laboratory service has enabled accelerated real-world implementation of the Cytosponge in the secondary care setting. This has enabled triage and care of patients who have not been able to access endoscopy during the COVID-19 pandemic.