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

Sarmed S. Sami, Prasad G Iyer, Prachi Pophali, Magnus Halland, Massimiliano di Pietro, Jacobo Ortiz-Fernandez-Sordo, Jonathan R. White, Michele Johnson, Indra Neil Guha, Rebecca C. Fitzgerald, Krish Ragunath

Research output: Contribution to journalArticle

6 Citations (Scopus)

Abstract

Background & Aims: 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. Methods: 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. Results: 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. Conclusions: 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.

Original languageEnglish (US)
Pages (from-to)638-646.e1
JournalClinical Gastroenterology and Hepatology
Volume17
Issue number4
DOIs
StatePublished - Mar 1 2019

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Capsule Endoscopy
Barrett Esophagus
Digestive System Endoscopy
Safety
Visual Analog Scale
Capsule Endoscopes
Nasopharynx
Patient Preference
Multicenter Studies
Registries
Cohort Studies
Referral and Consultation
Prospective Studies
Sensitivity and Specificity
Equipment and Supplies

Keywords

  • Esophageal Adenocarcinoma
  • Imaging
  • Office
  • Portable
  • Reflux

ASJC Scopus subject areas

  • Hepatology
  • Gastroenterology

Cite this

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

In: Clinical Gastroenterology and Hepatology, Vol. 17, No. 4, 01.03.2019, p. 638-646.e1.

Research output: Contribution to journalArticle

Sami, SS, Iyer, PG, Pophali, P, Halland, M, di Pietro, M, Ortiz-Fernandez-Sordo, J, White, JR, Johnson, M, Guha, IN, Fitzgerald, RC & Ragunath, K 2019, 'Acceptability, Accuracy, and Safety of Disposable Transnasal Capsule Endoscopy for Barrett's Esophagus Screening', Clinical Gastroenterology and Hepatology, vol. 17, no. 4, pp. 638-646.e1. https://doi.org/10.1016/j.cgh.2018.07.019
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. / Acceptability, Accuracy, and Safety of Disposable Transnasal Capsule Endoscopy for Barrett's Esophagus Screening. In: Clinical Gastroenterology and Hepatology. 2019 ; Vol. 17, No. 4. pp. 638-646.e1.
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AU - Iyer, Prasad G

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AU - Halland, Magnus

AU - di Pietro, Massimiliano

AU - Ortiz-Fernandez-Sordo, Jacobo

AU - White, Jonathan R.

AU - Johnson, Michele

AU - Guha, Indra Neil

AU - Fitzgerald, Rebecca C.

AU - Ragunath, Krish

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N2 - Background & Aims: 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. Methods: 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. Results: 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. Conclusions: 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.

AB - Background & Aims: 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. Methods: 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. Results: 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. Conclusions: 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.

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