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对比 MiroCam 和 EndoCapsule 的小肠成像的随机头对头研究。

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

机构信息

Division of Gastroenterology and Hepatology, Department of Internal Medicine III, Medical University of Vienna, Austria.

出版信息

Endoscopy. 2012 Nov;44(11):1012-20. doi: 10.1055/s-0032-1310158. Epub 2012 Aug 28.

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.

摘要

背景与研究目的

MiroCam 是一种新型视频胶囊设备,具有更高的帧率和更长的电池预期寿命。我们旨在量化其临床影响,并对其与 EndoCapsule 设备进行随机头对头比较,比较完全小肠检查率、小肠诊断率和胶囊通过时间。

患者和方法

因不明原因胃肠道出血、慢性腹泻和贫血而接受视频胶囊内镜检查的患者被随机分配先吞服 MiroCam,2 小时后再吞服 EndoCapsule,或者反之。所有视频均由两名独立的调查员进行分析。

结果

共纳入 50 例患者(中位年龄 61 岁,范围 21-84 岁)。使用 MiroCam 实现完全小肠检查的患者为 48/50 例,使用 EndoCapsule 的为 45/50 例(96% vs. 90%,比值比 [OR] 2.67,95%置信区间 [CI] 0.49-14.45;P=0.38)。使用 MiroCam 的 25/50 例患者和使用 EndoCapsule 的 24/50 例患者的小肠有诊断价值(50% vs. 48%,OR 1.08,95%CI 0.49-2.37;P>0.99)。然而,仅 68%的结果是一致的(kappa = 0.50)。联合诊断率为 58%。即使是单独的发现,在 6 个月的随访期间也有相关的临床影响。

结论

在这项直接比较中,MiroCam 和 EndoCapsule 设备在完全小肠检查率或诊断率方面没有统计学差异。它们的中等一致性,主要是由于两个设备都遗漏了病理发现,这需要在临床实践中考虑。

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