Prospective multicenter performance evaluation of the second-generation colon capsule compared with colonoscopy

R. Eliakim, K. Yassin, Y. Niv, Y. Metzger, J. Lachter, E. Gal, B. Sapoznikov, F. Konikoff, G. Leichtmann, Z. Fireman, Y. Kopelman, S. N. Adler

Research output: Contribution to journalArticlepeer-review

281 Scopus citations

Abstract

Background and study aims: A second-generation capsule endoscopy system, using the PillCam Colon 2, was developed to increase sensitivity for colorectal polyp detection compared with the first-generation system. The performance of this new system is reported. Patients and methods: In a five-center feasibility study, second-generation capsule endoscopy was prospectively compared with conventional colonoscopy as gold standard for the detection of colorectal polyps and other colonic disease, in a cohort of patients scheduled for colonoscopy and having known or suspected colonic disease. Colonoscopy was independently performed within 10 hours after capsule ingestion. Capsule-positive but colonoscopy-negative cases were counted as false-positive. Results: 104 patients (mean age 49.8 years) were enrolled; data from 98 were analyzed. Patient rate for polyps of any size was 44%, 53% of these patients having adenomas. No adverse events related to either procedure were reported. The capsule sensitivity for the detection of patients with polyps 6mm was 89% (95% confidence interval [CI] 7097) and for those with polyps 10mm it was 88% (95%CI 5698), with specificities of 76% (95%CI 7278) and 89% (95%CI 8690), respectively. Both polyps missed by colonoscopy and mismatch in polyp size by study definition lowered specificity. Overall colon cleanliness for capsule endoscopy was adequate in 78% of patients (95%CI 6886). Conclusions: The new second-generation colon capsule endoscopy is a safe and effective method for visualizing the colon and detecting colonic lesions. Sensitivity and specificity for detecting colorectal polyps appear to be very good, suggesting a potential for improved accuracy compared with the first-generation system. Further prospective and comparative studies are needed.

Original languageEnglish
Pages (from-to)1026-1031
Number of pages6
JournalEndoscopy
Volume41
Issue number12
DOIs
StatePublished - 2009
Externally publishedYes

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