结肠镜检查与常规筛查条件下的常规结肠镜检查比较。
Colon Capsule Endoscopy compared to Conventional Colonoscopy under routine screening conditions.
机构信息
Department of Gastroenterology and Hepatology, University Hospital Basel, Petersgraben 4, 4031 Basel, Switzerland.
出版信息
BMC Gastroenterol. 2010 Jun 18;10:66. doi: 10.1186/1471-230X-10-66.
BACKGROUND
Colonoscopy (CSPY) for colorectal cancer screening has several limitations. Colon Capsule Endoscopy (PillCam Colon, CCE) was compared to CSPY under routine screening conditions.
METHODS
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.
RESULTS
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%.
CONCLUSION
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.
TRIAL REGISTRATION
NCT00991003.
背景
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。
方法
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。
结果
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%。
结论
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。
试验注册
NCT00991003。
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