Acceptability, Accuracy, and Safety of Disposable Transnasal Capsule Endoscopy for Barrett's Esophagus Screening

• Published in: Clinical gastroenterology and hepatology Vol. 17; no. 4; pp. 638 - 646.e1
• Main Authors: Sami, Sarmed S., Iyer, Prasad G., Pophali, Prachi, Halland, Magnus, di Pietro, Massimiliano, Ortiz-Fernandez-Sordo, Jacobo, White, Jonathan R., Johnson, Michele, Guha, Indra Neil, Fitzgerald, Rebecca C., Ragunath, Krish
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01.03.2019
• Subjects: Adult; Aged; Aged, 80 and over; Barrett Esophagus - diagnosis; Capsule Endoscopy - adverse effects; Capsule Endoscopy - methods; Esophageal Adenocarcinoma; Female; Humans; Imaging; Male; Mass Screening - adverse effects; Mass Screening - methods; Middle Aged; Office; Patient Acceptance of Health Care - statistics & numerical data; Patient Safety - statistics & numerical data; Portable; Prospective Studies; Reflux; Sensitivity and Specificity; United Kingdom; United States; United States; United Kingdom; Reflux; Office; Portable; BE; SSBE; Imaging; Esophageal Adenocarcinoma; LSBE; VAS; TNE; IQR; C-EGD
• ISSN: 1542-3565; 1542-7714; 1542-7714
• DOI: 10.1016/j.cgh.2018.07.019

Screening for Barrett’s esophagus (BE) with conventional esophagogastroduodenoscopy (C-EGD) is expensive. We assessed the performance of a clinic-based, single use transnasal capsule endoscope (EG Scan II) for the detection of BE, compared to C-EGD as the reference standard. We performed a prospective multicenter cohort study of patients with and without BE recruited from 3 referral centers (1 in the United States and 2 in the United Kingdom). Of 200 consenting participants, 178 (89%) completed both procedures (11% failed EG Scan due to the inability to intubate the nasopharynx). The mean age of participants was 57.9 years and 67% were male. The prevalence of BE was 53%. All subjects underwent the 2 procedures on the same day, performed by blinded endoscopists. Patients completed preference and validated tolerability (10-point visual analogue scale [VAS]) questionnaires within 14 days of the procedures. A higher proportion of patients preferred the EG Scan (54.2%) vs the C-EGD (16.7%) (P < .001) and the EG Scan had a higher VAS score (7.2) vs the C-EGD (6.4) (P = .0004). No serious adverse events occurred. The EG Scan identified any length BE with a sensitivity value of 0.90 (95% CI, 0.83–0.96) and a specificity value of 0.91 (95% CI, 0.82–0.96). The EG Scan identified long segment BE with a sensitivity value of 0.95 and short segment BE with a sensitivity values of 0.87. In a prospective study, we found the EG Scan to be safe and to detect BE with higher than 90% sensitivity and specificity. A higher proportion of patients preferred the EG Scan to C-EGD. This device might be used as a clinic-based tool to screen populations at risk for BE. ISRCTN registry identifier: 70595405; ClinicalTrials.gov no: NCT02066233.