肝硬化患者有急性水出血的内镜的时间:多中心随机对照试验的协议
Xingshun Qi1, Yiling Li2, Bimin Li3
1Liver Cirrhosis Study Group, Department of Gastroenterology, General Hospital of Northern Theater Command, No. 83 Wenhua Road, Shenyang, Liaoning Province 110840, China.
Therapeutic advances in gastroenterology
|November 14, 2024
概括
这项研究调查了肝硬化患者急性水出血的早期与延迟内镜. 它旨在确定早期内镜能否改善出血控制和生存结果.
科学领域:
- 胃肠病学 胃肠病学
- 肝病学 肝病学是一种肝病学.
- 干预性内镜检查是干预性的内镜检查.
背景情况:
- 肝硬化中的急性上部胃肠道出血 (AUGIB),特别是急性水出血 (AVB),需要及时进行内镜干预.
- 由于有限的高质量证据和"早期"内镜的不一致定义,对AVB患者内镜的最佳时间仍在争论中.
- 目前的证据主要来自非随机化研究,突出了对强有力的临床试验的需求.
研究的目的:
- 评估早期 (12小时内) 与延迟 (12-24小时) 内镜对AVB的肝硬化患者临床结果的影响.
- 从多中心随机对照试验 (RCT) 提供高质量的证据,以指导临床实践关于内镜时间.
- 评估早期内镜能否改善出血控制并降低该患者群体的死亡率.
主要方法:
- 一个多中心RCT涉及368名疑似AVB的肝硬化患者.
- 根据肝功能严重程度和临床表现分层的患者,然后随机分配1:1到早期或延迟内镜组.
- 主要结局:5天出血控制失败和6周再出血率;次要结局:6周死亡率和不良事件.
主要成果:
- 本部分应在研究完成后填写.
结论:
- 本RCT旨在提供高质量的证据,证明早期内镜对于治疗肝硬化患者的AVB的有效性.
- 结果将澄清早期内镜干预是否与延迟内镜相比改善出血控制和生存率.
- 这项研究旨在解决当前关于这个高风险组内镜术最佳时间的争议.
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