全球前的ERCP案例系列使用一次性十二指镜
Marco J Bruno1, Torsten Beyna2, David Carr-Locke3
1Department of Gastroenterology and Hepatology, Erasmus Medical Center, University Medical Center, Rotterdam, The Netherlands.
Endoscopy
|July 18, 2023
概括
单次使用的十二指管镜在各种场合的内镜逆行胆血管细胞造影 (ERCP) 中表现出良好的程序性成功. 经验丰富和不那么经验丰富的内镜医生报告了高设备性能评级.
科学领域:
- 胃肠病学 胃肠病学
- 医疗器械 医疗器械
- 内镜检查是指内镜检查.
背景情况:
- 第一个一次性使用的十二指望镜于2019年12月获得FDA批准.
- 在内镜逆行胆血管细胞造影 (ERCP) 中使用一次性十二指镜的数据需要在各种情况下和经验水平.
研究的目的:
- 评估ERCP程序中的第一个商业化一次性十二指镜的性能和安全性.
- 在多个国际学术中心评估ERCP完成率,设备性能和不良事件.
主要方法:
- 在11个国家的22个学术中心的61名内镜医生对551名成年患者进行了ERCP.
- 结果包括ERCP完成,跨向可重复使用设备,设备性能评级和严重不良事件 (SAE).
主要成果:
- 在使用一次性十二指镜的情况下,ERCP在96.0%的病例中完成,其中91.3%没有交叉完成.
- 完成时间中位数为24.0分钟,满意度中位数为8.0/10.
- 严重不良事件发生在7.8%的患者中,包括3.1%的ERCP后胰腺炎.
结论:
- 第一个市场上销售的一次性十二指镜在学术中心表现出良好的ERCP程序成功.
- 具有不同经验水平的内镜师报告了设备的高性能评级.
- 这项研究支持一次性十二指镜在各种ERCP环境中的实用性.
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