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早期与晚期的胰腺支架放置用于预防ERCP后胰腺炎:多中心随机临床试验的协议
Shaofei Wang1,2, Bingqing Bai2, Jianglong Hong2
1Department of Gastroenterology, Suzhou First People's Hospital, Suzhou, Anhui Province, 234000, China.
Trials
|June 3, 2025
概括
这项研究调查了早期与晚期的胰腺支架放置,以预防ERCP后胰腺炎 (PEP). 结果将确定在接受ERCP的患者中预防性胰腺支架的最佳时间.
科学领域:
- 胃肠病学 胃肠病学
- 干预性内镜检查是干预性的内镜检查.
- 临床试验 临床试验
背景情况:
- 胰腺支架在减少ERCP后胰腺炎 (PEP) 的发生和严重程度方面是有效的.
- 预防性胰腺支架放置的最佳时间在未来的试验中仍未确定.
- 这项研究侧重于接受ERCP的天真乳头患者.
研究的目的:
- 为了比较早期与晚期的胰腺支架放置在预防PEP.
- 确定预防性胰腺支架的最佳时间,以减少PEP的发生率和严重程度.
主要方法:
- EVL试验是一项多中心,单盲,随机对照试验,涉及768名患者.
- 患有难以胆管通道的ERCP患者将随机选择早期或晚期的胰腺支架.
- 主要结局:PEP的发生率和严重程度. 二次结果:高胺血症,支架成功,以及与ERCP相关的不良事件.
主要成果:
- 目前,EVL试验正在招募患者,但尚未产生结果.
- 目前正在进行数据收集和分析,以确定主要和次要结果.
结论:
- 该EVL试验旨在提供关键的洞察力,以了解胰腺支架放置的最佳时间,以预防PEP.
- 研究结果有可能显著影响ERCP实践和患者的治疗结果.
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