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A correction has been published: N Engl J Med 2009;361(12):1220.
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Background An ingestible capsule consisting of an endoscope equipped with a video camera at both ends was designed to explore the colon. This study compared capsule endoscopy with optical colonoscopy for the detection of colorectal polyps and cancer.
Methods We performed a prospective, multicenter study comparing capsule endoscopy with optical colonoscopy (the standard for comparison) in a cohort of patients with known or suspected colonic disease for the detection of colorectal polyps or cancer. Patients underwent an adapted colon preparation, and colon cleanliness was graded from poor to excellent. We computed the sensitivity and specificity of capsule endoscopy for polyps, advanced adenoma, and cancer.
Results A total of 328 patients (mean age, 58.6 years) were included in the study. The capsule was excreted within 10 hours after ingestion and before the end of the lifetime of the battery in 92.8% of the patients. The sensitivity and specificity of capsule endoscopy for detecting polyps that were 6 mm in size or bigger were 64% (95% confidence interval [CI], 59 to 72) and 84% (95% CI, 81 to 87), respectively, and for detecting advanced adenoma, the sensitivity and specificity were 73% (95% CI, 61 to 83) and 79% (95% CI, 77 to 81), respectively. Of 19 cancers detected by colonoscopy, 14 were detected by capsule endoscopy (sensitivity, 74%; 95% CI, 52 to 88). For all lesions, the sensitivity of capsule endoscopy was higher in patients with good or excellent colon cleanliness than in those with fair or poor colon cleanliness. Mild-to-moderate adverse events were reported in 26 patients (7.9%) and were mostly related to the colon preparation.
Conclusions The use of capsule endoscopy of the colon allows visualization of the colonic mucosa in most patients, but its sensitivity for detecting colonic lesions is low as compared with the use of optical colonoscopy. (ClinicalTrials.gov number, NCT00604162
[ClinicalTrials.gov]
.)
Source Information
From the Department of Gastroenterology, Erasme University Hospital, Université Libre de Bruxelles, Brussels (A.V.G., N.S., J.D.); Digestive Diseases Division, University of Navarra Clinic, Pamplona, Spain (M.M.-N., I.F.-U., C.C.); the Department of Internal Medicine and Digestive Diseases, Hôpital de Brabois, Centre Hospitalier Universitaire de Nancy, Nancy, France (G.G., M.D.); Service d'Hépato-Gastroentérologie, Hôpital Edouard-Herriot, Lyon, France (M.G.L., T.P.); the Department of Internal Medicine, Evangelisches Krankenhaus, Düsseldorf, Germany (H.N., M.P.); the Digestive Endoscopy Unit, Catholic University, A. Gemelli University Hospital, Rome (G.C., M.E.R., G.S., L.P.); Wolfson Unit for Endoscopy, St. Mark's Hospital, Imperial College, London, London (C.F., A.P., A.F.); and the 1st Medical Department, Asklepios Klinik Altona, Hamburg, Germany (F.H., M.K.).
This article (10.1056/NEJMoa0806347) was last updated on September 16, 2009, at NEJM.org.
Address reprint requests to Dr. Van Gossum at the Department of Gastroenterology, Hepatopancreatology, and Gastrointestinal Oncology, Erasme University Hospital, Université Libre de Bruxelles, Route de Lennik 808, 1070 Brussels, Belgium, or at andre.vangossum{at}erasme.ulb.ac.be.
Related Letters:
Capsule Endoscopy versus Colonoscopy
Hassan C., Zullo A., Hsu C.-S., Kao J.-H., Van Gossum A., Devière J., Bretthauer M.
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N Engl J Med 2009;
361:1608-1610, Oct 15, 2009.
Correspondence
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