新型便携式内镜系统用于上消化道内镜检查的实验研究
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1.海军军医大学附属长海医院;2.海军军医大学附属长海医院消化内科;3.广东潮州陆战军医院

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军内重大专项(AWS15J003)


An animal experimental study of a new portable endoscopic system for upper gastrointestinal endoscopy
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Shanghai Changhai Hospital Navy Military Medical University

Fund Project:

Major Military Projects Specialized (AWS15J003)

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    摘要:

    目的 通过动物实验初步评估新型便携式内镜系统用于上消化道内镜检查的操作性能、有效性和安全性。方法 采用平行对照、非劣效研究,选取10头健康巴拿猪作为研究对象,1名内镜医师使用日本Olympus内镜系统(型号GIF-Q260),另一名内镜医师使用新型便携式内镜系统,对10头健康巴拿猪按照先新型便携式内镜系统后Olympus内镜系统的顺序进行上消化道内镜检查,采用量化评分指标,对新型便携式内镜系统进行器械质量评价、图像质量评价和安全性评价。结果 新型便携式内镜系统单人操作时,展开和收纳用时分别为(110.24±8.93)s和(91.33±11.59)s,戴内镜一次性保护套用时(233.48±17.06)s。器械质量评价方面,新型便携式内镜系统的水气吸引性能不如Olympus内镜系统,吸引400 mL生理盐水所需时间为(56.44±5.18)s,用时多于Olympus内镜系统(型号GIF-Q260)的(33.71±3.56)s,但本新型便携式内镜系统吸引仍符合医疗器械技术要求(吸引量>400 mL/min);其他性能(包括整机密封性、活检通道、镜身坚柔、旋钮操作、镜身弯曲度、视野范围)与Olympus内镜系统相当。图像质量评价方面,新型便携式内镜系统的性能(包括图像清晰度、图像变形及失真、图像颜色分辨率、图像照度、图像质量综合评价)与Olympus内镜系统相近。安全性评价方面,仅使用Olympus内镜系统操作时有1头猪出现恶心症状,使用新型便携式内镜系统操作时的10头猪未发生呕吐、咽喉部出血、心脏骤停等不良事件。结论 新型便携式内镜系统展收方便,操作安全性好,内镜操作性能和有效性与临床常用内镜系统相当,不足之处在于水气吸引性能略差于临床常用内镜系统,但仍符合医疗器械技术要求,可以满足上消化道内镜检查。

    Abstract:

    Objective To evaluate the operating performance, effectiveness and safety of a new portable endoscopic system for upper gastrointestinal endoscopy in an animal model. Methods A parallel control, non-inferiority study was designed. Ten healthy Bana pigs were selected as the study subjects, and underwent upper gastrointestinal endoscopy using portable endoscope followed by Olympus GIF-Q260 endoscope. The instrument quality, image quality and safety of the new system were evaluated by means of quantitative scores. Results The time for deployment and installing of the new portable endoscopic system during single operation was 110.24±8.93 s and 91.33±11.59 s, respectively, and the time for the endoscope with disposable protective cover was 233.48±17.06 s. The time of attracting 400 mL normal saline of the portable endoscope and Olympus endoscope was 56.44±5.18 s and 33.71±3.56 s, respectively. The water vapor attraction performance of the portable endoscope was not as good as the Olympus endoscope, but still met the technical requirements of medical devices (attraction capacity >400 mL/min). While in terms of the seal property, biopsy channel, softness and curvature of gastroscopy body, knob operation, and field of view, the two endoscopic systems were equivalent. In terms of image quality evaluation, including clarity, distortion, color resolution, illumination and quality comprehensive evaluation, the performance of the new portable endoscopic system was similar to that of the Olympus endoscopic system. One pig developed nausea during operation with the Olympus endoscope. No adverse events occurred during operation with the new portable endoscope. Conclusion The new portable endoscopic system is easy to assemble. In terms of device quality, image quality and safety, the new portable endoscopic system is similar to the clinically used Olympus endoscopic system. Therefore, the new portable endoscope system is safe and effective for upper gastrointestinal endoscopy.

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朱春平,刘肖肖,王智杰,等.新型便携式内镜系统用于上消化道内镜检查的实验研究[J].中华消化内镜杂志,2020,37(4):249-252.

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  • 收稿日期:2019-10-17
  • 最后修改日期:2020-04-09
  • 录用日期:2019-11-07
  • 在线发布日期: 2020-04-30
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