Background. Colon capsule endoscopy (CCE) represents a noninvasive technology that allows visualization of the colon without requiring sedation and air insufflation. A second-generation colon capsule endoscopy system (PillCam Colon 2) (CCE-2) was developed to increase sensitivity for colorectal polyp detection compared with the firstgeneration system. Objective. To assess the feasibility, accuracy, and safety of CCE-2 in a head-to-head comparison with colonoscopy. Design and Setting. Prospective, multicenter trial including 8 European sites. Patients: This study involved 117 patients (mean age 60 years). Data from 109 patients were analyzed. Intervention. CCE-2 was prospectively compared with conventional colonoscopy as the criterion standard for the detection of colorectal polyps that are ≥6 mm or masses in a cohort of patients at average or increased risk of colorectal neoplasia. Colonoscopy was independently performed within 10 hours after capsule ingestion or on the next day. Main Outcome Measurements. CCE-2 sensitivity and specificity for detecting patients with polyps ≥6 mm and ≥10 mm were assessed. Capsule-positive but colonoscopynegative cases were counted as false positive. Capsule excretion rate, level of bowel preparation, and rate of adverse events also were assessed. Results. Per-patient CCE-2 sensitivity for polyps ≥6 mm and ≥10 mm was 84% and 88%, with specificities of 64% and 95%, respectively. All 3 invasive carcinomas were detected by CCE-2. The capsule excretion rate was 88% within 10 hours. Overall colon cleanliness for CCE-2 was adequate in 81% of patients. Limitations. Not unblinding the CCE-2 results at colonoscopy; heterogenous patient population; nonconsecutive patients. Conclusion. In this European, multicenter study, CCE-2 appeared to have a high sensitivity for the detection of clinically relevant polypoid lesions, and it might be considered an adequate tool for colorectal imaging.Abbreviations: CCE-2, second-generation colon capsule endoscopy; PEG, polyethylene glycol.
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.