Safety and Acceptability of Esophageal Cytosponge Cell Collection Device in a Pooled Analysis of Data from Individual Patients

Abstract

BACKGROUND AND AIMS Diagnosis and surveillance of Barrett’s esophagus (BE) and eosinophilic esophagitis (EoE) have become emerging public health issues. Cytosponge® is a novel, minimally invasive esophageal cell collection device. We aimed to assess the data on safety and acceptability of this device. METHODS We performed a patient-level review of 5 prospective trials assessing Cytosponge® performance in patients with reflux disease, BE and EoE in primary and secondary care. Acceptability of Cytosponge® and subsequent endoscopy were recorded with visual analogue scale (VAS), wherein 0 and 10 denoted lowest and highest acceptability. Median VAS scores were compared using a Mann-Whitney test. The number of attempts, failures in swallowing the device and occurrence of adverse events were analyzed. Risk factors for failure in swallowing were analyzed using a multivariate regression model. RESULTS In total 2,672 Cytosponge® procedures were performed in 2,418 individuals between 2008 and 2017. There were two adverse events related to the device: a minor pharyngeal bleed and one case of detachment (<1:2,000). The median acceptability score for the Cytosponge® was 6.0 (IQR 5.0-8.0), which was higher than endoscopywithout sedation (median 5.0, IQR 3.0-7.0; p<0.001) and lower than endoscopy with sedation (median 8.0, IQR 5.0-9.0; p<0.001). Nearly all patients (91.1%) successfully swallowed the Cytosponge® and most (90.1%) were achieved with the first swallow attempt. Failure to swallow the device was more likely to occur in secondary care (OR= 5.13, 95%CI 1.48-17.79, P<0.01). CONCLUSIONS The Cytosponge® test is a safe procedure with good acceptability ratings in a variety of health care settings.