Acceptability and Adequacy of a Non-endoscopic Cell Collection Device for Diagnosis of Barrett’s Esophagus: Lessons Learned

Abstract

Background

Endoscopic screening for Barrett’s esophagus (BE) is common, costly, and underperformed in at-risk people. A non-endoscopic cell collection device can be used to collect esophageal cells, enabling BE screening.

Aims

This study assessed the acceptability and adequacy of a commercial non-endoscopic cell collection device in a US population.

Methods

Six sites enrolled patients with confirmed BE or heartburn/regurgitation for ≥ 6 months. Patients underwent administration of the device, consisting of a sponge encapsulated in a capsule. The capsule dwelled in the stomach for 7.5 min and was retracted via an attached suture. An adequate sample was ≥ 1 columnar cell by H&E staining. Sample quality was rated using a 0–5 scale, with 0 = no columnar cells and 5 = plentiful groups. Trefoil Factor 3 (TFF3) staining was performed. Accuracy was assessed using esophagogastroduodenoscopy (EGD)/biopsy as the gold standard.

Results

Of 191 patients, 99.5% successfully swallowed the device. Overall sample adequacy was 91% (171/188), with 84% (158/188) high quality. The detachment rate was 2/190 (1%). Overall sensitivity, specificity, and accuracy of the assay with TFF3 staining were 76%, 77%, and 76%. Sensitivity, specificity, and accuracy for ≥ 3 cm BE were 86%, 77%, and 82%. Asked if willing to repeat the procedure, 93% would, and 65% indicated a preference for the device over EGD.

Conclusions

This study demonstrated a high rate of sample adequacy and promising acceptability of this non-endoscopic sampling device in a US population. Diagnostic characteristics suggest that non-endoscopic assessment of BE deserves further development as an alternative to endoscopy.

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Acknowledgments

The authors thank the staff and participants of the study for their valuable contributions. Alex Shih, PhD (Medtronic), provided statistical support and Katherine E. Liu, PhD (Medtronic), provided medical writing support for this study.

Funding

This study was funded by Medtronic.

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Authors

Contributions

All authors were involved in the design, data collection, data analysis or data interpretation of this study. NS drafted the manuscript and all authors participated in revision of the manuscript for important intellectual content.

Corresponding author

Correspondence to Nicholas J. Shaheen.

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Conflict of interest

Nicholas J. Shaheen has served as a consultant for Cernostics, Lucid, and Cook Medical, and has received research funding from Medical, C2 Therapeutics, Medtronic, Interpace Diagnostics, CDx Medical, EndoStim and Ironwood Pharmaceuticals. Maria O’Donovan has served as a consultant for Medtronic plc. She is named on patents relating to the original Cytosponge design and TFF3 assay licensed to Medtronic. She is a cofounder of Cyted Ltd. V. Raman Muthusamy has served as a consultant for Boston Scientific, Interpace Diagnostics, Medtronic, and Torax Medical (Ethicon), and has received research funding from Boston Scientific and Medtronic. Sachin Wani has served as a consultant for Boston Scientific, Medtronic, Interpace Diagnostics and Cernostics.

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All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards.

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Informed consent was obtained from all individual participants included in the study.

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Shaheen, N.J., Komanduri, S., Muthusamy, V.R. et al. Acceptability and Adequacy of a Non-endoscopic Cell Collection Device for Diagnosis of Barrett’s Esophagus: Lessons Learned. Dig Dis Sci (2021). https://doi.org/10.1007/s10620-021-06833-6

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Keywords

  • Barrett’s esophagus
  • Screening
  • Non-endoscopic
  • Esophageal adenocarcinoma