Feasibility and Safety of Tethered Capsule Endomicroscopy in Patients With Barrett's Esophagus in a Multi-Center Study

Jing Dong, Catriona Grant, Barry Vuong, Norman Nishioka, Anna Huizi Gao, Matthew Beatty, Grace Baldwin, Aaron Baillargeon, Ara Bablouzian, Patricia Grahmann, Nitasha Bhat, Emily Ryan, Amilcar Barrios, Sarah Giddings, Timothy Ford, Emilie Beaulieu-Ouellet, Seyed Hamid Hosseiny, Irene Lerman, Wolfgang Trasischker, Rohith ReddyKanwarpal Singh, Michalina Gora, Daryl Hyun, Lucille Quénéhervé, Michael Wallace, Herbert Wolfsen, Prateek Sharma, Kenneth K. Wang, Cadman L. Leggett, John Poneros, Julian A. Abrams, Charles Lightdale, Samantha Leeds, Mireille Rosenberg, Guillermo J. Tearney

Research output: Contribution to journalArticlepeer-review

Abstract

Background & Aims: Tethered capsule endomicroscopy (TCE) involves swallowing a small tethered pill that implements optical coherence tomography (OCT) imaging, procuring high resolution images of the whole esophagus. Here, we demonstrate and evaluate the feasibility and safety of TCE and a portable OCT imaging system in patients with Barrett's esophagus (BE) in a multi-center (5-site) clinical study. Methods: Untreated patients with BE as per endoscopic biopsy diagnosis were eligible to participate in the study. TCE procedures were performed in unsedated patients by either doctors or nurses. After the capsule was swallowed, the device continuously obtained 10-μm-resolution cross-sectional images as it traversed the esophagus. Following imaging, the device was withdrawn through mouth, and disinfected for subsequent reuse. BE lengths were compared to endoscopy findings when available. OCT-TCE images were compared to volumetric laser endomicroscopy (VLE) images from a patient who had undergone VLE on the same day as TCE. Results: 147 patients with BE were enrolled across all sites. 116 swallowed the capsule (79%), 95/114 (83.3%) men and 21/33 (63.6%) women (P =.01). High-quality OCT images were obtained in 104/111 swallowers (93.7%) who completed the procedure. The average imaging duration was 5.55 ± 1.92 minutes. The mean length of esophagus imaged per patient was 21.69 ± 5.90 cm. A blinded comparison of maximum extent of BE measured by OCT-TCE and EGD showed a strong correlation (r = 0.77-0.79). OCT-TCE images were of similar quality to those obtained by OCT-VLE. Conclusions: The capabilities of TCE to be used across multiple sites, be administered to unsedated patients by either physicians or nurses who are not expert in OCT-TCE, and to rapidly and safely evaluate the microscopic structure of the esophagus make it an emerging tool for screening and surveillance of BE patients. Clinical trial registry website and trial number: NCT02994693 and NCT03459339.

Original languageEnglish (US)
JournalClinical Gastroenterology and Hepatology
DOIs
StateAccepted/In press - 2021

Keywords

  • Barrett's Esophagus
  • Optical Coherence Tomography
  • Tethered Capsule Endomicroscopy

ASJC Scopus subject areas

  • Hepatology
  • Gastroenterology

Fingerprint

Dive into the research topics of 'Feasibility and Safety of Tethered Capsule Endomicroscopy in Patients With Barrett's Esophagus in a Multi-Center Study'. Together they form a unique fingerprint.

Cite this