Second-generation colon capsule endoscopy compared with colonoscopy

Cristiano Spada, Cesare Hassan, Miguel Munoz-Navas, Horst Neuhaus, Jacques Deviere, Paul Fockens, Emmanuel Coron, Gerard Gay, Ervin Toth, Maria Elena Riccioni, Cristina Carretero, Jean P. Charton, André Van Gossum, Carolien A. Wientjes, Sylvie Sacher-Huvelin, Michel Delvaux, Artur Nemeth, Lucio Petruzziello, Cesar Prieto De Frias, Rupert MayershoferLeila Aminejab, Evelien Dekker, Jean Paul Galmiche, Muriel Frederic, Gabriele Wurm Johansson, Paola Cesaro, Guido Costamagna

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Abstract

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.

Original languageEnglish
Pages (from-to)581-589.e1
JournalGastrointestinal endoscopy
Volume74
Issue number3
DOIs
Publication statusPublished - Sep 2011

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ASJC Scopus subject areas

  • Radiology Nuclear Medicine and imaging
  • Gastroenterology

Cite this

Spada, C., Hassan, C., Munoz-Navas, M., Neuhaus, H., Deviere, J., Fockens, P., Coron, E., Gay, G., Toth, E., Riccioni, M. E., Carretero, C., Charton, J. P., Van Gossum, A., Wientjes, C. A., Sacher-Huvelin, S., Delvaux, M., Nemeth, A., Petruzziello, L., De Frias, C. P., ... Costamagna, G. (2011). Second-generation colon capsule endoscopy compared with colonoscopy. Gastrointestinal endoscopy, 74(3), 581-589.e1. https://doi.org/10.1016/j.gie.2011.03.1125