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一项经比较MiroCam与EndoCapsule对小肠成像的头对头的随机化研究

发布日期:2014-1-29 12:40:59 文章来源:GIE 作者次数:3576
    奥地利维也纳医科大学,内科医学系,肝病与肠胃病部

    摘要

    背景与研究目的:MiroCam是一种拥有更高帧频和更长电池使用寿命的新型视频胶囊设备。我们的目的是量化MiroCam的临床影响力,并通过在小肠完整检查率、诊断利用率和胶囊内镜通过时间等方面进行一项与EndoCapsule设备的头对头的随机化比较研究。

    患者与方法:患有隐蔽肠胃出血、慢性腹泻、原因不明贫血接受胶囊视频内镜的病人会被随机安排吞下MiroCam,间隔两小时后再吞下EndoCapcule,或者采用相反的吞服顺序。所有的视频信息会由两位独立的研究者分析。

    研究结果:共有50位病人参加此项试验(年龄范围21-84岁,中位年龄61岁)。50例患者中有48例通过MiroCam进行了完整小肠检查,而有45例患者通过EndoCapsule进行了此项检查(96%90%,让步比:2.6795%置信区间:0.49-14.45P=0.36)。采用MiroCam25例病人(共50例)小肠进行了诊断,采用EndoCapsule24例病人(共50例)小肠提供了诊断.(两者诊断率为50%48%,让步比:1.0895%置信区间:0.49-2.37P>0.99)。不过,仅68%的患者检查结果是一致的(kappa=0.50)。两者联合诊断率为58%。在6个月的随访期间,即使采用单一胶囊的,其研究结果也会有着相当大的临床学影响力。

    结论:在此直接对比实验中,在小肠完整检查率或诊断率方面,MrioCam EndoCapsule 两种装置并没有什么统计上的区别。主要因为缺失病理结果,这会对两种设备产生影响,从而导致两者一致性一般,因此在临床实践中还需考虑这二者的一致性。


    A randomized head-to-head study of small-bowel imaging comparing MiroCam and EndoCapsule

    W. Dolak, S. Kulnigg-Dabsch, R. Evstatiev, C. Gasche, M. Trauner, A. Püspök

    Division of Gastroenterology and Hepatology, Department of Internal Medicine III, Medical University of Vienna,Austriasubmitted 11122011
    accepted after revision 15062012
    Publication Date:
    28 August 2012 (eFirst)

    Abstract

    Background and study aims: The MiroCam is a new video capsule device offering a higher frame rate and a longer battery life-expectancy. We aimed to quantify its clinical impact and performed a randomized head-to-head comparison with the EndoCapsule device with respect to the rate of complete small-bowel examinations, diagnostic yield in the small bowel, and capsule transit time.

    Patients and methods: Patients referred for video capsule endoscopy because of obscure gastrointestinal bleeding, chronic diarrhea, and anemia of unknown origin were randomly assigned to swallow either the MiroCam first, followed by the EndoCapsule 2 hours later, or vice versa. All videos were analyzed by two independent investigators.

    Results: A total of 50 patients (median age 61, range 21 - 84) were included. Complete small-bowel examination was achieved in 48 /50 patients using the MiroCam and 45 /50 using the EndoCapsule (96 % vs. 90 %, odds ratio [OR] 2.67, 95 % confidence interval [CI] 0.49 - 14.45; P = 0.38). There was diagnostic yield in the small bowel for 25 /50 patients using the MiroCam and 24 /50 using the EndoCapsule (50 % vs. 48 %, OR 1.08, 95 %CI 0.49 - 2.37; P > 0.99). However, the findings were concordant in 68 % only (kappa = 0.50). The combined diagnostic yield was 58 %. Even solitary findings had a relevant clinical impact during a 6-month follow-up.

    Conclusion: In this direct comparison the MiroCam and EndoCapsule devices were not statistically different with regard to their rates of complete small-bowel examinations or diagnostic yield. Their moderate concordance, mainly caused by missed pathological findings, which affected both devices, needs consideration in clinical practice.

     

     

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