Prospective Multicenter Performance Evaluation of the Second-Generation Colon Capsule Compared with Colonoscopy

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 colo-rectal 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 ≥ 6 mm was 89 % (95 % confidence -interval “CI” 70-97) and for those with polyps ≥ 10 mm it was 88 % (95 % CI 56-98), with speci-ficities of 76 % (95 % CI 72-78) and 89 % (95 % CI 86-90), 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 68-86). 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, sug-gest-ing a potential for improved accuracy compared with the first-generation system. Further pro-spec-tive and comparative studies are needed.