Ont Health Technol Assess Ser. 2015 Jul 1;15(14):1-39. eCollection 2015.
BACKGROUND: Colorectal cancer, a leading cause of mortality and morbidity in Ontario, can be prevented through early diagnosis and removal of precancerous polyps. Colon capsule endoscopy is a relatively new, minimally invasive test for detecting colorectal polyps. OBJECTIVE: The objectives of this analysis were to evaluate the diagnostic accuracy and safety of colon capsule endoscopy for the detection of colorectal polyps among adult patients with signs or symptoms of colorectal cancer or with increased risk of colorectal cancer, and to compare colon capsule endoscopy with alternative procedures. REVIEW METHODS: A literature search was performed using Ovid MEDLINE, Ovid MEDLINE In-Process and Other Non-Indexed Citations, Ovid EMBASE, the Wiley Cochrane Library, and the Centre for Reviews and Dissemination database, for studies published between 2006 and 2014. Data on diagnostic accuracy and safety were abstracted from included studies. Quality of evidence was assessed using Grading of Recommendations Assessment, Development, and Evaluation (GRADE). RESULTS: The search yielded 2,189 citations. Five studies, all of which evaluated PillCam COLON 2 (PCC2), met the inclusion criteria. The per-patient sensitivity and specificity for detecting colorectal polyps were meta-analyzed. Colon capsule endoscopy, using PCC2, had a pooled sensitivity and specificity of 87% (95% confidence interval [CI] 77%-93%) and 76% (95% CI 60%-87%), respectively, for the detection of a colorectal polyp at least 6 mm in size (GRADE: very low). PCC2 had a pooled sensitivity and specificity of 89% (95% CI 77%-95%) and 91% (95% CI 86%-95%), respectively, for the detection of a colorectal polyp at least 10 mm in size (GRADE: low). One study directly compared PCC2 with computed tomographic (CT) colonography and found no statistically significant difference in accuracy (GRADE: low). Few adverse events were reported with PCC2; 3.9% of patients (95% CI 2.4%-6.5%) experienced adverse effects related to bowel preparation. Capsule retention was the most serious adverse event and occurred in 0.8% of patients (95% CI 0.2%-2.4%) (GRADE: very low). CONCLUSIONS: In adult patients with signs, symptoms, or increased risk of colorectal cancer, there is low-quality evidence that colon capsule endoscopy using the PCC2 device has good sensitivity and specificity for detecting colorectal polyps. Low-quality evidence does not show a difference in accuracy between colon capsule endoscopy and CT colonography. There is very low-quality evidence that PCC2 has a good safety profile with few adverse events; capsule retention is the most serious complication.
背景:结直肠癌是安大略省死亡和发病的主要原因之一,可通过早期诊断和切除癌前息肉来预防。结肠胶囊内镜检查是一种相对较新的、用于检测结直肠息肉的微创检查方法。 目的:本分析的目的是评估结肠胶囊内镜检查在有结直肠癌体征或症状或结直肠癌风险增加的成年患者中检测结直肠息肉的诊断准确性和安全性,并将结肠胶囊内镜检查与其他替代检查方法进行比较。 综述方法:使用Ovid MEDLINE、Ovid MEDLINE在研及其他未索引引文、Ovid EMBASE、Wiley Cochrane图书馆和循证医学图书馆数据库进行文献检索,检索2006年至2014年发表的研究。从纳入研究中提取有关诊断准确性和安全性的数据。使用推荐分级的评估、制定和评价(GRADE)对证据质量进行评估。 结果:检索共获得2189条引文。五项研究均评估了第二代结肠胶囊内镜(PCC2),符合纳入标准。对每位患者检测结直肠息肉的敏感性和特异性进行了荟萃分析。使用PCC2的结肠胶囊内镜检查对至少6毫米大小的结直肠息肉检测的合并敏感性和特异性分别为87%(95%置信区间[CI]77%-93%)和76%(95%CI 60%-87%)(证据质量等级:极低)。PCC2对至少10毫米大小的结直肠息肉检测的合并敏感性和特异性分别为89%(95%CI 77%-95%)和91%(95%CI 86%-95%)(证据质量等级:低)。一项研究直接将PCC2与计算机断层扫描(CT)结肠成像进行比较,发现准确性无统计学显著差异(证据质量等级:低)。PCC2报告的不良事件很少;3.9%的患者(95%CI 2.4%-6.5%)经历了与肠道准备相关的不良反应。胶囊滞留是最严重的不良事件,发生在0.8%的患者中(95%CI 0.2%-2.4%)(证据质量等级:极低)。 结论:在有结直肠癌体征、症状或风险增加的成年患者中,低质量证据表明使用PCC2设备的结肠胶囊内镜检查在检测结直肠息肉方面具有良好的敏感性和特异性。低质量证据未显示结肠胶囊内镜检查和CT结肠成像在准确性上存在差异。极低质量证据表明PCC2安全性良好,不良事件很少;胶囊滞留是最严重的并发症。
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