Mo1526 Tethered Capsule Endoscope (TCE) Versus Standard EGD for Screening for Barrett's Esophagus (BE): Preliminary Results From a Blinded Pilot Study

Abstract

BackgroundA prototype TCE that uses scanned low-power red, green and blue (RGB) laser light was developed for visualizing the esophagus during an unsedated procedure. The forward-viewing TCE capsule is 6.4 mm diameter and 18mm length with a soft flexible tether of 1.4 mm diameter at the proximal end (Figure 1). Along the tether is an identical 1.4 mm diameter tube that allows for air insufflation with a manual squeeze bulb. Endoscopic images can be viewed in white (RGB) light or enhanced blue band imaging (Figure 2).Figure 2TCE images of the squamocolumnar junction in white light (RGB) and enhanced blue band imaging (right lower image)View Large Image Figure ViewerDownload Hi-res image Download (PPT)AimTo evaluate the clinical performance of the TCE for identifying BE and patient preference for unsedated TCE versus conventional EGD.MethodsPatients undergoing diagnostic EGD or BE screening/surveillance were scheduled for TCE testing immediately before their conventional EGD. A single clinician performing the TCE was blinded to the indication for EGD. After consent, 5 subjects (4 men, mean age 67 years) swallowed the TCE in a seated position with sips of water. The clinician controlled TCE position axially in the esophagus while both patient and physician watched the same video monitor. Endoscopic findings were recorded prior to sedated EGD (performed by a second endoscopist, blinded to the TCE results). Post-procedure questionnaires were completed by the subject and both endoscopists, and a follow-up subject questionnaire was conducted one week later.ResultsThe TCE procedure time ranged from 10-13 minutes. EGD identified 2 subjects with circumferential suspected BE and 1 with a tongue of suspected BE. TCE correctly classified these 3 subjects, but also incorrectly identified one additional subject with a 1.5 cm tongue of suspected BE (i.e. no BE was seen on EGD). TCE identified one esophageal erosion that was found to be a site of “puckered mucosa” corresponding to a healing esophageal ulcer seen on a prior EGD. TCE correctly classified 1 of 4 subjects with hiatal hernia on EGD (2 of the other 3 were classified as “unsure” on TCE). Subjects reported no pain and no or only minor discomfort during the TCE procedure (and none afterwards). All rated TCE as comfortable or better and convenient (n=1) or very convenient (n=4). One week following EGD, the subjects recalled no pain or discomfort with the TCE procedure. The TCE was rated as comfortable (n=3) or very comfortable (n=2) by all. EGD with sedation was associated with no pain or discomfort during the procedure. One subject reported minor pain and minor discomfort post-EGD. EGD was deemed only tolerable by 1 subject and comfortable (n=2) or very comfortable (n=2) by the others. One subject preferred and 4 subjects strongly preferred the TCE procedure to EGD.ConclusionUnsedated TCE can detect suspected BE, is very well tolerated and is strongly preferred over sedated EGD. A larger sample of subjects is required to determine the sensitivity and specificity of TCE. BackgroundA prototype TCE that uses scanned low-power red, green and blue (RGB) laser light was developed for visualizing the esophagus during an unsedated procedure. The forward-viewing TCE capsule is 6.4 mm diameter and 18mm length with a soft flexible tether of 1.4 mm diameter at the proximal end (Figure 1). Along the tether is an identical 1.4 mm diameter tube that allows for air insufflation with a manual squeeze bulb. Endoscopic images can be viewed in white (RGB) light or enhanced blue band imaging (Figure 2). A prototype TCE that uses scanned low-power red, green and blue (RGB) laser light was developed for visualizing the esophagus during an unsedated procedure. The forward-viewing TCE capsule is 6.4 mm diameter and 18mm length with a soft flexible tether of 1.4 mm diameter at the proximal end (Figure 1). Along the tether is an identical 1.4 mm diameter tube that allows for air insufflation with a manual squeeze bulb. Endoscopic images can be viewed in white (RGB) light or enhanced blue band imaging (Figure 2). AimTo evaluate the clinical performance of the TCE for identifying BE and patient preference for unsedated TCE versus conventional EGD. To evaluate the clinical performance of the TCE for identifying BE and patient preference for unsedated TCE versus conventional EGD. MethodsPatients undergoing diagnostic EGD or BE screening/surveillance were scheduled for TCE testing immediately before their conventional EGD. A single clinician performing the TCE was blinded to the indication for EGD. After consent, 5 subjects (4 men, mean age 67 years) swallowed the TCE in a seated position with sips of water. The clinician controlled TCE position axially in the esophagus while both patient and physician watched the same video monitor. Endoscopic findings were recorded prior to sedated EGD (performed by a second endoscopist, blinded to the TCE results). Post-procedure questionnaires were completed by the subject and both endoscopists, and a follow-up subject questionnaire was conducted one week later. Patients undergoing diagnostic EGD or BE screening/surveillance were scheduled for TCE testing immediately before their conventional EGD. A single clinician performing the TCE was blinded to the indication for EGD. After consent, 5 subjects (4 men, mean age 67 years) swallowed the TCE in a seated position with sips of water. The clinician controlled TCE position axially in the esophagus while both patient and physician watched the same video monitor. Endoscopic findings were recorded prior to sedated EGD (performed by a second endoscopist, blinded to the TCE results). Post-procedure questionnaires were completed by the subject and both endoscopists, and a follow-up subject questionnaire was conducted one week later. ResultsThe TCE procedure time ranged from 10-13 minutes. EGD identified 2 subjects with circumferential suspected BE and 1 with a tongue of suspected BE. TCE correctly classified these 3 subjects, but also incorrectly identified one additional subject with a 1.5 cm tongue of suspected BE (i.e. no BE was seen on EGD). TCE identified one esophageal erosion that was found to be a site of “puckered mucosa” corresponding to a healing esophageal ulcer seen on a prior EGD. TCE correctly classified 1 of 4 subjects with hiatal hernia on EGD (2 of the other 3 were classified as “unsure” on TCE). Subjects reported no pain and no or only minor discomfort during the TCE procedure (and none afterwards). All rated TCE as comfortable or better and convenient (n=1) or very convenient (n=4). One week following EGD, the subjects recalled no pain or discomfort with the TCE procedure. The TCE was rated as comfortable (n=3) or very comfortable (n=2) by all. EGD with sedation was associated with no pain or discomfort during the procedure. One subject reported minor pain and minor discomfort post-EGD. EGD was deemed only tolerable by 1 subject and comfortable (n=2) or very comfortable (n=2) by the others. One subject preferred and 4 subjects strongly preferred the TCE procedure to EGD. The TCE procedure time ranged from 10-13 minutes. EGD identified 2 subjects with circumferential suspected BE and 1 with a tongue of suspected BE. TCE correctly classified these 3 subjects, but also incorrectly identified one additional subject with a 1.5 cm tongue of suspected BE (i.e. no BE was seen on EGD). TCE identified one esophageal erosion that was found to be a site of “puckered mucosa” corresponding to a healing esophageal ulcer seen on a prior EGD. TCE correctly classified 1 of 4 subjects with hiatal hernia on EGD (2 of the other 3 were classified as “unsure” on TCE). Subjects reported no pain and no or only minor discomfort during the TCE procedure (and none afterwards). All rated TCE as comfortable or better and convenient (n=1) or very convenient (n=4). One week following EGD, the subjects recalled no pain or discomfort with the TCE procedure. The TCE was rated as comfortable (n=3) or very comfortable (n=2) by all. EGD with sedation was associated with no pain or discomfort during the procedure. One subject reported minor pain and minor discomfort post-EGD. EGD was deemed only tolerable by 1 subject and comfortable (n=2) or very comfortable (n=2) by the others. One subject preferred and 4 subjects strongly preferred the TCE procedure to EGD. ConclusionUnsedated TCE can detect suspected BE, is very well tolerated and is strongly preferred over sedated EGD. A larger sample of subjects is required to determine the sensitivity and specificity of TCE. Unsedated TCE can detect suspected BE, is very well tolerated and is strongly preferred over sedated EGD. A larger sample of subjects is required to determine the sensitivity and specificity of TCE.