TY - JOUR
T1 - Feasibility and Safety of Tethered Capsule Endomicroscopy in Patients With Barrett's Esophagus in a Multi-Center Study
AU - Dong, Jing
AU - Grant, Catriona
AU - Vuong, Barry
AU - Nishioka, Norman
AU - Gao, Anna Huizi
AU - Beatty, Matthew
AU - Baldwin, Grace
AU - Baillargeon, Aaron
AU - Bablouzian, Ara
AU - Grahmann, Patricia
AU - Bhat, Nitasha
AU - Ryan, Emily
AU - Barrios, Amilcar
AU - Giddings, Sarah
AU - Ford, Timothy
AU - Beaulieu-Ouellet, Emilie
AU - Hosseiny, Seyed Hamid
AU - Lerman, Irene
AU - Trasischker, Wolfgang
AU - Reddy, Rohith
AU - Singh, Kanwarpal
AU - Gora, Michalina
AU - Hyun, Daryl
AU - Quénéhervé, Lucille
AU - Wallace, Michael
AU - Wolfsen, Herbert
AU - Sharma, Prateek
AU - Wang, Kenneth K.
AU - Leggett, Cadman L.
AU - Poneros, John
AU - Abrams, Julian A.
AU - Lightdale, Charles
AU - Leeds, Samantha
AU - Rosenberg, Mireille
AU - Tearney, Guillermo J.
N1 - Publisher Copyright:
© 2022 AGA Institute
PY - 2022/4
Y1 - 2022/4
N2 - 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 Following imaging, the device was withdrawn through mouth, and disinfected for subsequent reuse.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.
AB - 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.
KW - Barrett's Esophagus
KW - Optical Coherence Tomography
KW - Tethered Capsule Endomicroscopy
UR - http://www.scopus.com/inward/record.url?scp=85106578106&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85106578106&partnerID=8YFLogxK
U2 - 10.1016/j.cgh.2021.02.008
DO - 10.1016/j.cgh.2021.02.008
M3 - Article
C2 - 33549871
AN - SCOPUS:85106578106
SN - 1542-3565
VL - 20
SP - 756-765.e3
JO - Clinical Gastroenterology and Hepatology
JF - Clinical Gastroenterology and Hepatology
IS - 4
ER -