Original ResearchFull Report: Clinical—Alimentary TractAccuracy of Capsule Colonoscopy in Detecting Colorectal Polyps in a Screening Population
Section snippets
Equipment and Study End Points
The PillCam COLON 2 (Given Imaging Inc, Yoqneam, Israel) capsule was used in this study. The PillCam COLON 2 system includes the second-generation ingestible capsule, sensors attached to the abdomen that receive capsule images, a data recorder, and a software package that displays the images on a workstation and can create procedure reports.
The primary end point of this prospective study was the accuracy (sensitivity and specificity) of the PillCam COLON 2 for detecting patients with polyps 6
Exclusions
Figure 1 diagrams the initial enrollment cohort to the final analysis cohort. Of 884 asymptomatic subjects enrolled, 695 were included in the analysis of all polyps. Six patients did not have a pathology report, therefore 689 were included in the adenoma analysis. The mean age of the 689 subjects was 57 years, and 56% were female.
There were 77 subjects (9%) excluded for both inadequate cleansing and whole-colon transit time fewer than 40 minutes. Forty-five subjects dropped out before the
Discussion
This report describes a capsule endoscopy study for colorectal polyp detection in asymptomatic persons.
Several aspects of the study design and the results of this trial are important to consider because they indicate that a complete understanding of capsule performance relative to colonoscopy is difficult to achieve. First, polyps were matched by colon segment whereas in previous trials of the second-generation capsule polyps were matched by the entire colon.2, 3 When we performed a secondary
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Conflicts of interest These authors disclose the following: Douglas Rex and Samuel Adler have received consulting fees from Given Imaging, Inc; Cristina Carretero has received speaker’s fees and fees for central reading from Given Imaging, Inc; Ignacio Fernandez-Urien Sainz, Wai-Keung Leung, Neofytos Papageorgiou, and Matti Waterman have received fees for central reading from Given Imaging, Inc.
Given Imaging, Inc, participated in the study design, provided funding, participated in data analysis, review, and comment on the manuscript.
The remaining authors disclose no conflicts.
Funding Supported by Given Imaging, Inc.