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

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Januszewicz, Wladyslaw 
Tan, Wei Keith 
Lehovsky, Katie 
Debiram-Beecham, Irene 
Nuckcheddy, Tara 

BACKGROUND & 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, 2672 Cytosponge procedures were performed, in 2418 individuals from 2008 through 2017. There were 2 adverse events related to the device: a minor pharyngeal bleed and a case of detachment (<1:2000). The median acceptability score for the Cytosponge was 6.0 (interquartile range [IQR], 5.0-8.0), which was higher than the score for endoscopy without sedation (median 5.0; IQR, 3.0-7.0; P < .001) and lower than the score for endoscopy with sedation (median 8.0; IQR, 5.0-9.0; P < .001). Nearly all patients (91.1%) successfully swallowed the Cytosponge, most on the first attempt (90.1%). Failure to swallow the device was more likely to occur in secondary care (odds ratio, 5.13; 95% CI, 1.48-17.79; P < .01). CONCLUSIONS: The Cytosponge test is a safe procedure with good acceptability ratings in a variety of health care settings.

Acceptability of Healthcare, Medical Device, Safety, Aged, Barrett Esophagus, Cytological Techniques, Eosinophilic Esophagitis, Equipment and Supplies, Female, Humans, Male, Mass Screening, Middle Aged, Patient Acceptance of Health Care, Patient Safety, Prospective Studies, Retrospective Studies, Risk Factors, Specimen Handling
Journal Title
Clin Gastroenterol Hepatol
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Elsevier BV
Cancer Research Uk (None)
MRC (unknown)
Medical Research Council (MC_UU_12022/2)
National Institute of Diabetes and Digestive and Kidney Diseases (K24DK100548)
Cancer Research UK (C14478/A12088)