Department of Gastroenterology and Hepatology, University Hospital Basel, Petersgraben 4, 4031 Basel, Switzerland.
BMC Gastroenterol. 2010 Jun 18;10:66. doi: 10.1186/1471-230X-10-66.
Colonoscopy (CSPY) for colorectal cancer screening has several limitations. Colon Capsule Endoscopy (PillCam Colon, CCE) was compared to CSPY under routine screening conditions.
We 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.
59 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%.
In 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.
NCT00991003.
结肠镜检查（CSPY）用于结直肠癌筛查有几个局限性。在常规筛查条件下，胶囊内镜（PillCam Colon，CCE）与 CSPY 进行了比较。
我们在一家大学医院进行了一项前瞻性、单中心的试点研究。数据于 2007 年 11 月至 2008 年 5 月获得。患者在第 1 天进行 CCE，在第 2 天进行 CSPY。评估了息肉检出率的灵敏度和特异性，以>5mm 为显著性水平。
这项研究纳入了 59 名患者，其中 56 名患者的结果可评估（男性 34 名，女性 22 名；中位年龄 59 岁）。36 例患者 CCE 检查完成。CSPY 检测到的有意义息肉的息肉检出率为 11%，CCE 为 27%。6/56（11%）名患者在 CSPY 上发现的息肉在 CCE 上未被发现（漏诊率）。总体灵敏度为 79%（95%置信区间，61%至 90%），特异性为 54%（95%置信区间，35%至 70%），阳性预测值（PPV）为 63%，阴性预测值（NPV）为 71%。调整到发现的显著性，灵敏度为 50%（95%置信区间，19%至 81%），特异性为 76%（95%置信区间，63%至 86%），PPV 为 20%，NPV 为 93%。
与金标准相比，CCE 检测相关息肉的灵敏度较低，但高 NPV 支持其作为一种可能的筛查工具的作用。
NCT00991003。
