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

Nicholas J. Shaheen*, Srinadh Komanduri, V. Raman Muthusamy, Sachin Wani, Maria O’Donovan, Rajinder Kaushal, John M. Haydek

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

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 The capsule dwelled in the stomach for 7.5 min and was retracted via an attached suture.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.

Original languageEnglish (US)
JournalDigestive diseases and sciences
DOIs
StateAccepted/In press - 2021

Keywords

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

ASJC Scopus subject areas

  • Physiology
  • Gastroenterology

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