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比较第二代结肠胶囊內镜与结肠镜

发布日期:2014-1-29 12:40:20 文章来源:GIE 作者次数:1147
    背景
    结肠胶囊內镜(CCE)是一种无创性检查手段,可以使结肠无需镇静和空气注入而实现可视化。与第一代系统相比,开发第二代结肠胶囊內镜系统(PillCam Colon 2) (CCE-2)是为了增加大肠息肉检查灵敏度。
    目的
    评估第二代结肠胶囊內镜检查(CCE-2)的可行性,准确性和安全性,并一对一的与结肠镜检查术比较。
    设计与环境
    前瞻性,多中心实验且包括8座欧洲城市。
    患者
    本研究有117例患者参加(平均年龄为60岁)。且分析了109例患者资料。
    干预
    在一个有着平均或更高形成结直肠瘤风险的队列中,前瞻性比较第二代结肠胶囊內镜(CCE-2)与作为大肠息肉(大于6mm或者肿块)检测规范标准的普通结肠镜。在胶囊摄取后10小时内或第二天单独实施结肠镜检查。
    主要测量指标
    评估第二代结肠胶囊內镜(CCE-2)检测患者息肉(大于6 mm和10 mm)的灵敏度和特异性。胶囊镜检查为阳性但结肠镜检查为阴性的病例被视为假阳性。同时本研究还评估胶囊排泄率,肠道准备情况和不良反应发生概率。
    结果
    第二代结肠胶囊內镜(CCE-2)对每例患者息肉(大于6 mm和10 mm)的检测灵敏度分别为84%和88%,特异性分别为64%和95%。3例侵润性癌均被第二代结肠胶囊內镜系统(CCE-2)检测到。10小时内胶囊排泄率为88%。第二代结肠胶囊內镜系统(CCE-2)的整体清洁度对81%的患者来说是合适的。
    局限性
    第二代结肠胶囊內镜检测(CCE-2)结果在结肠镜检查时不揭盲;患者群不均一;患者不连续。
    结论
    在这项欧洲多中心研究中,第二代结肠胶囊內镜系统(CCE-2)似乎对临床相关息肉病变有着较高的检测灵敏度,而且它可能被视为结直肠成像的一种恰当手段。
    缩写词:CCE-2为第二代结肠胶囊內镜检查,PEG为聚乙二醇
     
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    Background
    Colon capsule endoscopy (CCE) represents a noninvasive technology that allows visualization of the colon without requiring sedation and air insufflation. A second-generation colon capsule endoscopy system (PillCam Colon 2) (CCE-2) was developed to increase sensitivity for colorectal polyp detection compared with the first-generation system.
    Objective
    To assess the feasibility, accuracy, and safety of CCE-2 in a head-to-head comparison with colonoscopy.
    Design and Setting
    Prospective, multicenter trial including 8 European sites.
    Patients
    This study involved 117 patients (mean age 60 years). Data from 109 patients were analyzed.
    Intervention
    CCE-2 was prospectively compared with conventional colonoscopy as the criterion standard for the detection of colorectal polyps that are ≥6 mm or masses in a cohort of patients at average or increased risk of colorectal neoplasia. Colonoscopy was independently performed within 10 hours after capsule ingestion or on the next day.
    Main Outcome Measurements
    CCE-2 sensitivity and specificity for detecting patients with polyps ≥6 mm and ≥10 mm were assessed. Capsule-positive but colonoscopy-negative cases were counted as false positive. Capsule excretion rate, level of bowel preparation, and rate of adverse events also were assessed.
    Results
    Per-patient CCE-2 sensitivity for polyps ≥6 mm and ≥10 mm was 84% and 88%, with specificities of 64% and 95%, respectively. All 3 invasive carcinomas were detected by CCE-2. The capsule excretion rate was 88% within 10 hours. Overall colon cleanliness for CCE-2 was adequate in 81% of patients.
    Limitations
    Not unblinding the CCE-2 results at colonoscopy; heterogenous patient population; nonconsecutive patients.
    Conclusion
    In this European, multicenter study, CCE-2 appeared to have a high sensitivity for the detection of clinically relevant polypoid lesions, and it might be considered an adequate tool for colorectal imaging.
     
     
     
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