Development and clinical usability of a new traction device "medical ring" for endoscopic submucosal dissection of early gastric cancer.

Development and clinical usability of a new traction device "medical ring" for endoscopic submucosal dissection of early gastric cancer.
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DOI:
10.1007/s00464-013-2887-6
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发表时间:
2013-09
影响因子:
3.1
通讯作者:
Watanabe, Sumio
Watanabe, Sumio
中科院分区:
医学2区
文献类型:
--
作者:
Matsumoto, Kenshi;Nagahara, Akihito;Ueyama, Hiroya;Konuma, Hironori;Morimoto, Takasi;Sasaki, Hitoshi;Hayashi, Takuo;Shibuya, Tomoyoshi;Sakamoto, Naoto;Osada, Taro;Ogihara, Tatsuo;Yao, Takashi;Watanabe, Sumio

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尽管存在用于内镜粘膜下剥离术(ESD)的各种牵引器械,但尚未考虑器械中使用的材料对人体的影响。此外,还没有关于便于在病变的口腔侧和肛门侧进行剥离的装置的报告。我们制作了一种牵引装置,该装置对身体没有有害影响,并且是非侵入性的,易于使用,并且能够在ESD中实现双侧入路。我们报告的过程中,它的创建和其使用在实际的ESD程序的前瞻性评估。本研究为前瞻性病例对照研究。连续前瞻性入组了37例将使用该器械的患者(使用器械组)。随机选择不使用器械且病变大小和位置与使用器械组匹配的对照受试者(未使用器械组)。根据治疗难度将两组分为三个亚组:A组:容易; B组:中等; C组:困难。观察各组每平方厘米解剖时间。未使用器械组/使用器械组的剥离时间如下:A组,5.8/2.1 min/cm 2(p < 0.01); B组,6.1/3.8 min/cm 2(p < 0.05); C组,7.9/3.6 min/cm 2(p < 0.01)。新开发的医用环被证明是可行和安全的,通过适当的张力可以实现良好的可视化,并促进快速胃ESD。本文的在线版本(doi:10.1007/s 00464 -013-2887-6)包含补充材料,可供授权用户使用。
Although various traction devices exist for endoscopic submucosal dissection (ESD), the effects of the material used in the devices on the human body has not been considered. Moreover, there has been no report on a device that facilitates dissection both on the oral and anal side of the lesion. We made a traction device that has no deleterious effects on the body and is noninvasive, easy to use, and enables a bilateral approach in ESD. We report the process of its creation and a prospective evaluation of its usage in actual ESD procedures. This study is prospective case control study. Thirty-seven patients for whom the device would be used were consecutively and prospectively enrolled (device used group). Control subjects in whom the device would not be used and who had lesions matched for size and location with those of the device used group were randomly selected (device not used group). Both groups were classified into three subgroups according to treatment difficulty: group A: easy; group B: intermediate; and group C: difficult. The dissection time per cm2 in each group was examined. Dissection times in the device not used group/device used group were as follows: group A, 5.8/2.1 min/cm2 (p < 0.01); group B, 6.1/3.8 min/cm2 (p < 0.05); and group C, 7.9/3.6 min/cm2 (p < 0.01), respectively. The newly developed medical ring was shown to be feasible and safe and allowed excellent visualization through suitable tension and facilitated rapid gastric ESD. The online version of this article (doi:10.1007/s00464-013-2887-6) contains supplementary material, which is available to authorized users.
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