Background and aims: Colonoscopy is regarded as the gold standard for colorectal cancer (CRC) screening. PillCam capsule endoscopy could be an alternative approach for screening large populations. We report a pilot evaluation in humans of the safety, feasibility, and performance of colon capsule endoscopy compared with colonoscopy. Patients and methods: Patients included in this single-center comparative study had presented for screening colonoscopy or there was suspicion of polyps or CRC. The capsule was ingested in the morning. After excretion, colonoscopy was performed. Significant findings were defined either as polyps > 6 mm, or three or more polyps of any size. Colonoscopy and colon capsule endoscopy (CCE) review were performed by independent physicians. Results: 41 patients (26 women), mean age 56 years (range 26 - 75) were included, and all had complete colonoscopies. Four patients were excluded due to technical problems and one could not swallow the capsule; thus, 36 patients were considered in the analysis. In six the capsule had not been expelled at 10 hours and was retrieved endoscopically. CCE identified 19 of the 25 patients (76 %) with positive findings and 10 of the 13 (77 %) with significant lesions detected by colonoscopy. CCE detected seven lesions not seen at colonoscopy and two tumors were detected by both examinations. Overall sensitivity of CCE to detect significant lesions was 77 %, specificity was 70 %, positive predictive value was 59 %, and negative predictive value was 84 %. No adverse events occurred. Conclusion: CCE showed promising accuracy compared with colonoscopy. This new noninvasive technique deserves further evaluation as a potential CRC screening tool.
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