用乳酸林格溶液和血溶液进行激烈的水分治疗,以预防内镜后逆行性胆固醇胰腺学图 (ERCP) 胰腺炎 (ALPS研究):多中心,双盲,随机对照试验的协议
In Rae Cho1, Jin Ho Choi2, Joo Kyung Park3
1Department of Internal Medicine and Liver Research Institute, Seoul National University Hospital, Jongno-gu, Seoul, Korea (the Republic of).
BMJ open
|July 2, 2024
概括
这项研究比较了乳酸林格溶液和血溶液,用于预防ERCP后胰腺炎 (PEP). 这项研究旨在改进接受内镜逆行胆血管细胞造影 (ERCP) 的患者的水化策略.
科学领域:
- 胃肠病学和肝病学 胃肠学和肝病学
- 临床试验 临床试验
- 医疗干预 医疗干预
背景情况:
- 内镜逆行胆血管瘤造影 (ERCP) 对于胰腺胆道疾病至关重要,但存在ERCP后胰腺炎 (PEP) 的风险.
- 目前的PEP预防策略是不完美的,强调了需要优化水分的方法.
- 这项研究侧重于天真乳头患者,这是PEP风险组.
研究的目的:
- 评估乳酸林格溶液与血溶液在预防PEP方面的有效性.
- 评估在接受ERCP的患者中预防PEP的水合策略.
- 确定二次结果,包括与ERCP相关的风险因素和不良事件.
主要方法:
- 一个多中心,双盲,随机对照试验,涉及844名患者.
- 具有天真乳头和中等至高风险的PEP参与者被随机分配给接受乳酸林格溶液或血溶液.
- 排除标准包括年龄≤18岁,严重的并发症和先前的胰腺炎.
主要成果:
- 主要结局:发生PEP.
- 二次结果:与ERCP相关的额外风险因素和潜在不良事件.
- 旨在检测干预手臂之间显著差异的研究,共844名参与者.
结论:
- 该研究将提供关于两种水合溶液在PEP预防方面的比较有效性的见解.
- 这些发现旨在完善ERCP程序的临床实践.
- 结果将通过同行评审的出版物和会议传播.
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