Abstract

BackgroundColonoscopy (CSPY) for colorectal cancer screening has several limitations. Colon Capsule Endoscopy (PillCam Colon, CCE) was compared to CSPY under routine screening conditions.MethodsWe performed a prospective, single-center pilot study at a University Hospital. Data were obtained from November 2007 until May 2008. Patients underwent CCE on Day 1 and CSPY on Day 2. Outcomes were evaluated regarding sensitivity and specificity of polyp detection rate, with a significance level set at >5 mm.Results59 individuals were included in this study, the results were evaluable in 56 patients (males 34, females 22; median age 59). CCE was complete in 36 subjects. Polyp detection rate for significant polyps was 11% on CSPY and 27% on CCE.6/56 (11%) patients had polyps on CSPY not detected on CCE (miss rate).Overall sensitivity was 79% (95% confidence interval [CI], 61 to 90), specificity was 54% (95% CI, 35 to 70), positive predictive value (PPV) was 63% and negative predictive value (NPV) was 71%. Adjusted to significance of findings, sensitivity was 50% (95% CI, 19 to 81), specificity was 76% (95% CI, 63 to 86), PPV was 20% and NPV was 93%.ConclusionIn comparison to the gold standard, the sensitivity of CCE for detection of relevant polyps is low, however, the high NPV supports its role as a possible screening tool.Trial RegistrationNCT00991003.

Highlights

  • Colonoscopy (CSPY) for colorectal cancer screening has several limitations

  • In comparison to the gold standard, the sensitivity of Colon capsule endoscopy (CCE) for detection of relevant polyps is low, the high negative predictive value (NPV) supports its role as a possible screening tool

  • Current evidence points to the important role of screening colonoscopy with subsequent polypectomy (CSPY), reducing the risk of developing CRC by 7690%[4,5,6]

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Summary

Introduction

Colonoscopy (CSPY) for colorectal cancer screening has several limitations. Colon Capsule Endoscopy (PillCam Colon, CCE) was compared to CSPY under routine screening conditions. The incidence of colorectal cancer [(CRC), standardized to age and world population] is 20-45/100.000 for men und 15-30/100.000 for women[1]. It is increasing with age[2] and the cumulative lifetime risk both for men and for women arises to 6%[3]. The majority (90%) of CRC develop from benign adenomatous polyps. Current evidence points to the important role of screening colonoscopy with subsequent polypectomy (CSPY), reducing the risk of developing CRC by 7690%[4,5,6]. Early recognization and removal of carcinomatous lesions is crucial, as 5-year survival rates for DUKES stage A (UICC 0 to 1) are above 90%, whereas overall 5-year-survival rate is 62%[7]

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