中国现代普通外科进展2024,Vol.27Issue(1) :14-18.DOI:10.3969/j.issn.1009-9905.2024.01.003

小型猪实验验证内镜逆行新视野的临床安全性及有效性

Clinical safety and validity analysis of retrograde new endo-scopic visual field in miniature pigs

匡哲 李鹏 金大庆 张永潮 郭慧丽 张宇飞 贺光琳 孙国锋 贺渊
中国现代普通外科进展2024,Vol.27Issue(1) :14-18.DOI:10.3969/j.issn.1009-9905.2024.01.003

小型猪实验验证内镜逆行新视野的临床安全性及有效性

Clinical safety and validity analysis of retrograde new endo-scopic visual field in miniature pigs

匡哲 1李鹏 1金大庆 2张永潮 3郭慧丽 3张宇飞 4贺光琳 5孙国锋 5贺渊5
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作者信息

  • 1. 首都医科大学附属北京友谊医院 消化内科(北京 100050)
  • 2. 北京市平谷区卫生健康委员会(北京 101200)
  • 3. 首都医科大学附属北京友谊医院平谷医院消化内科(北京 101200)
  • 4. 首都医科大学附属北京友谊医院平谷医院普外科(北京 101200)
  • 5. 杭州海康慧影科技有限公司(浙江 杭州 310051)
  • 折叠

摘要

目的:应用小型猪验证内镜逆行新视野的临床安全性及有效性.方法:选取6只活体小型猪作为研究对象,选用内镜逆行新视野(ERNV).评价其操作性能、图像质量并记录术中和术后并发症.评估实验动物能否全部完成相关内镜检查.验证ERNV的操作性能及能否顺利通过十二指肠镜进入胆管,明确注水、吸引及器械通道是否通畅.分析胆道镜图像清晰度、颜色分辨率,有无图像变形及失真,能否准确评估管腔内情况及清晰观察黏膜表面情况.观察检查过程中无出血、穿孔等操作性损伤,以及呼吸抑制、心脏骤停等不良事件.观察术后所有猪存活状态及有无不良反应.结果:6只小型猪胆道镜均成功置入胆管内,该产品操作性能较佳,可顺利通过十二指肠镜进入胆管,其注水、吸引及器械通道相对通畅.此外,内镜图像较为清晰、颜色分辨率较佳,且无变形和失真,可实现对管腔内情况的准确评估,较为清晰地观察黏膜表面情况.所有小型猪均未发生胆管狭窄或扩张,胆管黏膜较为光滑,无充血水肿,无黏膜血管的异常增粗或弯曲.检查过程中无出血、穿孔等操作性损伤,未发生呼吸抑制、心脏骤停等不良事件.术后所有小型猪各项生命体征均趋于稳定,存活状态良好,且无胆管炎、出血及穿孔等并发症.结论:ERNV临床安全性及有效性均较佳,具有操作性能佳、图像质量优等特点,值得临床推广应用.

Abstract

Objective:To study the clinical safety and validity of retrograde new endoscopic field of vision in miniature pigs.Methods:6 live miniature pigs were selected as study subjects,En-doscopic Retrograde New View(ERNV)was selected.The performance,image quality and intraoper-ative and postoperative complications were evaluated.To evaluate whether all the experimental ani-mals could complete the relevant endoscopy.Verify ERNV's operating performance,including whether the duodenoscope can enter the biliary tract smoothly,and made sure whether the injection,suction,and instrument channels were unobstructed.Choledochoscope image clarity,color resolu-tion,image deformation and distortion,accurate evaluation of lumen conditions and clear observation of mucosal surface conditions were analyzed.Whether there were operant injuries such as bleeding and perforation,as well as adverse events such as respiratory depression and cardiac arrest.The sur-vival status and adverse reactions of all pigs were observed.Results:The choledochoscope was successfully inserted into the bile duct of 6 miniature pigs.The product had good operation perfor-mance and could enter the bile duct through the duodenoscope smoothly.The injection,suction and instrument channels were relatively smooth.In addition,the endoscopic images are clear,with better color resolution,and without image deformation and distortion,which can realize accurate evaluation of the conditions in the lumen and observe the mucosal surface conditions more clearly.No bile duct stenosis or dilatation occurred in all miniature pigs,and the bile duct mucosa was smooth,without hyperemia and edema,and no abnormal thickening or bending of mucous vessels.During the exami-nation,there were no operational injuries such as bleeding and perforation,and no adverse events such as respiratory depression and cardiac arrest occurred.The vital signs of all miniature pigs tended to be stable after operation,and the survival state was good,and there were no complications such as cholangitis,bleeding and perforation.Conclusion:ERNV has good clinical safety and efficacy,ex-cellent operation performance and excellent image quality,and is worthy of clinical application.

关键词

动物实验/内镜/安全性/有效性/

Key words

Animal experiment/Endoscope/Security/Validity/Pig

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基金项目

北京市平谷区卫生健康委科研项目(pgwjw2020-06)

出版年

2024
中国现代普通外科进展
山东大学

中国现代普通外科进展

CSTPCD
影响因子:0.993
ISSN:1009-9905
参考文献量19
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