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美乐cam MC2000与智能药丸摄像头SB3在检测小肠出血中的比较研究:一项多中心前瞻性随机交叉研究。

Comparative Study of MiroCam MC2000 and PillCam SB3 in Detecting Small Bowel Bleeding: A Multicenter Prospective Randomized Crossover Study.

作者信息

Kim Ji Eun, Kim Eun Ran, Park Jae Jun, Kim Kyeong Ok, Park Yehyun, Yang Young Joo, Jang Hyun Joo

机构信息

Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.

Division of Gastroenterology, Department of Internal Medicine, Severance Hospital, Yonsei University College of Medicine, Seoul, Korea.

出版信息

Gut Liver. 2025 Jul 15;19(4):569-578. doi: 10.5009/gnl240541. Epub 2025 Apr 1.

Abstract

BACKGROUND/AIMS: The MiroCam MC2000 (MC2000) is a double-tip capsule with a camera on each side. It is designed to provide more extensive visualization of the small bowel mucosa, potentially reducing the chance of missing lesions. This study aimed to compare the detection rates for lesions in the ampulla of Vater (AoV) and the small bowel of the MC2000 and the PillCam SB3 (SB3) for patients with suspected small bowel bleeding.

METHODS

This prospective, multicenter, randomized crossover trial compared the lesion detection capabilities of the MC2000 and SB3 capsules, ingested one hour apart by patients with suspected small bowel bleeding. The primary outcome was the detection of lesions in the AoV, while the secondary outcome was the assessment of the detection of P1 and P2 lesions, known underlying causes of small bowel bleeding.

RESULTS

There was no significant difference in AoV lesion detection rates between the devices. However, MC2000 demonstrated significantly greater detection of red spots in patients with visible bleeding (p=0.018) and tended to detect a greater number of small bowel lesions, including P2 lesions. Minor complications included device stasis, with fewer incidents with the MC2000 than with the SB3, and one instance of small bowel retention due to ulcers.

CONCLUSIONS

The MC2000's dual-camera system appears to enhance the detection of small bowel lesions over the SB3, especially for more important lesions. These findings suggest that the MC2000 may offer superior diagnostic capabilities for patients with suspected small bowel bleeding, potentially leading to better clinical outcomes (this trial registered KCT0005591).

摘要

背景/目的:MiroCam MC2000(MC2000)是一种双侧带有摄像头的双尖端胶囊。其设计目的是更广泛地观察小肠黏膜,可能降低漏诊病变的几率。本研究旨在比较MC2000和PillCam SB3(SB3)对疑似小肠出血患者的 Vater壶腹(AoV)和小肠病变的检出率。

方法

这项前瞻性、多中心、随机交叉试验比较了MC2000和SB3胶囊对疑似小肠出血患者的病变检测能力,患者在相隔一小时的时间内分别摄入这两种胶囊。主要结局是AoV病变的检测,次要结局是对P1和P2病变(已知的小肠出血潜在病因)的检测评估。

结果

两种设备在AoV病变检出率上无显著差异。然而,MC2000在可见出血患者中对红点的检出率显著更高(p = 0.018),并且倾向于检测到更多的小肠病变,包括P2病变。轻微并发症包括设备滞留,MC2000的此类事件少于SB3,还有一例因溃疡导致的小肠潴留。

结论

MC2000的双摄像头系统似乎比SB3能更好地检测小肠病变,尤其是对于更重要的病变。这些发现表明,MC2000可能为疑似小肠出血患者提供更优的诊断能力,可能带来更好的临床结局(本试验注册号为KCT0005591)。

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