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

BEST1 and BEST2 study investigators

Research output: Contribution to journalArticle

14 Citations (Scopus)

Abstract

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.

Original languageEnglish (US)
Pages (from-to)647-656.e1
JournalClinical Gastroenterology and Hepatology
Volume17
Issue number4
DOIs
StatePublished - Mar 1 2019

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Deglutition
Eosinophilic Esophagitis
Endoscopy
Safety
Equipment and Supplies
Secondary Care
Barrett Esophagus
Visual Analog Scale
Protective Devices
Primary Health Care
Public Health
Odds Ratio
Delivery of Health Care

Keywords

  • Acceptability of Healthcare
  • Medical Device
  • Safety

ASJC Scopus subject areas

  • Hepatology
  • Gastroenterology

Cite this

Safety and Acceptability of Esophageal Cytosponge Cell Collection Device in a Pooled Analysis of Data From Individual Patients. / BEST1 and BEST2 study investigators.

In: Clinical Gastroenterology and Hepatology, Vol. 17, No. 4, 01.03.2019, p. 647-656.e1.

Research output: Contribution to journalArticle

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title = "Safety and Acceptability of Esophageal Cytosponge Cell Collection Device in a Pooled Analysis of Data From Individual Patients",
abstract = "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.",
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author = "{BEST1 and BEST2 study investigators} and Wladyslaw Januszewicz and Tan, {Wei Keith} and Katie Lehovsky and Irene Debiram-Beecham and Tara Nuckcheddy and Susan Moist and Sudarshan Kadri and {di Pietro}, Massimiliano and Alex Boussioutas and Shaheen, {Nicholas J.} and Katzka, {David A} and Dellon, {Evan S.} and Fitzgerald, {Rebecca C.}",
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AU - BEST1 and BEST2 study investigators

AU - Januszewicz, Wladyslaw

AU - Tan, Wei Keith

AU - Lehovsky, Katie

AU - Debiram-Beecham, Irene

AU - Nuckcheddy, Tara

AU - Moist, Susan

AU - Kadri, Sudarshan

AU - di Pietro, Massimiliano

AU - Boussioutas, Alex

AU - Shaheen, Nicholas J.

AU - Katzka, David A

AU - Dellon, Evan S.

AU - Fitzgerald, Rebecca C.

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