Galmiche, J.P. (Jean-Paul)

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    Second-generation colon capsule endoscopy compared with colonoscopy
    (2011) Carretero, C. (Cristina); Costamagna, G. (Guido); Galmiche, J.P. (Jean-Paul); Toth, E. (Ervin); Johansson, G.W. (Gabriele Wurn); Petruzziello, L. (Lucio); Hassan, C. (Cesare); Muñoz-Navas, M. (Miguel); Gossum, A. (Andre) van; Nemeth, A. (Artur); Delvaux, M. (Michel); Fockens, P. (Paul); Sacher-Huvelin, S. (Sylvie); Frederic, M. (Muriel); Aminejab, L. (Leila); Neuhaus, H. (Horst); Spada, C. (Cristiano); Riccioni, M.E. (Maria Elena); Deviere, J. (Jacques); Dekker, E. (Evelien); Wientjes, C.A. (Caroline A.); Prieto-Frías, C. (Cesár); Coron, E. (Emmanuel); Mayershofer, R. (Rupert); Gay, G. (Gerard); Cesaro, P. (Paola)
    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.
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    Second-generation colon capsule endoscopy compared with colonoscopy
    (Elsevier, 2011) Carretero, C. (Cristina); Costamagna, G. (Guido); Galmiche, J.P. (Jean-Paul); Toth, E. (Ervin); Johansson, G.W. (Gabriele Wurn); Petruzziello, L. (Lucio); Hassan, C. (Cesare); Muñoz-Navas, M. (Miguel); Prieto-Martínez, C. (Carlos); Gossum, A. (Andre) van; Nemeth, A. (Artur); Delvaux, M. (Michel); Fockens, P. (Paul); Sacher-Huvelin, S. (Sylvie); Frederic, M. (Muriel); Aminejab, L. (Leila); Neuhaus, H. (Horst); Spada, C. (Cristiano); Riccioni, M.E. (Maria Elena); Deviere, J. (Jacques); Dekker, E. (Evelien); Wientjes, C.A. (Caroline A.); Coron, E. (Emmanuel); Charton, J.P. (Jean P.); Mayershofer, R. (Rupert); Gay, G. (Gerard); Cesaro, P. (Paola)
    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.