Second-generation colon capsule endoscopy compared with colonoscopy.


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 first-generation 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 colonoscopy-negative 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.

DOI: 10.1016/j.gie.2011.03.1125

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@article{Spada2011SecondgenerationCC, title={Second-generation colon capsule endoscopy compared with colonoscopy.}, author={C. Spada and Cesare Hassan and Miguel A Mu{\~n}oz-Navas and Horst Neuhaus and Jacques Devi{\'e}re and Paul Fockens and E Coron and G{\'e}rard Gay and Ervin T{\'o}th and Maria Elena Riccioni and Cristina Carretero and Jean Pierre Charton and Andre M Van Gossum and Carolien A Wientjes and Sylvie Sacher-Huvelin and Michel M Delvaux and Art{\'u}r N{\'e}meth and Lucio Petruzziello and Cesar Prieto de Frias and Rupert Mayershofer and Leila Amininejad and Evelien Dekker and Jean Paul Galmiche and Muriel Fr{\'e}d{\'e}ric and Gabriele Wurm Johansson and Paola Cesaro and Guido Costamagna}, journal={Gastrointestinal endoscopy}, year={2011}, volume={74 3}, pages={581-589.e1} }