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Second-generation colon capsule endoscopy compared with colonoscopy

2011; Elsevier BV; Volume: 74; Issue: 3 Linguagem: Inglês

10.1016/j.gie.2011.03.1125

1097-6779

Cristiano Spada, Cesare Hassan, Miguel Muñoz‐Navas, Horst Neuhaus, Jacques Devière, Paul Fockens, Emmanuel Coron, Gérard Gay, Ervin Tóth, Maria Elena Riccioni, Cristina Carretero, Jean Pierre Charton, A. Van Gossum, C Wientjes, Sylvie Sacher‐Huvelin, Michel Delvaux, Artúr Németh, Lucio Petruzziello, César Prieto de Frías, Rupert Mayershofer, Leila Aminejab, Evelien Dekker, Jean–Paul Galmiche, Muriel Frederic, Gabriele Wurm Johansson, Paola Cesaro, Guido Costamagna,

Gastrointestinal Bleeding Diagnosis and Treatment

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.