双极血静止与标准治疗的血 + / - 上腺素注射作为初始内镜治疗在活跃的非的上部肠道出血:研究协议的前性,随机的多中心试验 (BeBop-试验) 试验
Daniel Schmitz1, Lucas Thielemann2, Felix Grassmann3
1Department of Gastroenterology and Infectiology, Helios Kliniken Schwerin, University Campus of Medical School Hamburg, Wismarsche Str.393-397, Schwerin, 19055, Germany. Daniel.Schmitz@helios-gesundheit.de.
Trials
|June 15, 2023
概括
这项研究旨在调查双极管是否比标准治疗更有效,以治疗活跃的非变节性上部胃肠道出血. 结果将确定这些常见出血事件的最佳内镜治疗.
科学领域:
- 胃肠病学 胃肠病学
- 内镜血液静止症 (Endoscopic Hemostasis) 是一种内镜血液静止症.
- 临床试验 临床试验
背景情况:
- 使用血栓和/或上腺素注射治疗活跃的非上胃肠道出血 (NVUGIB) 的标准治疗并不总是成功.
- 双极血静止已被批准用于胃肠道出血,但它们作为活性NVUGIB的主要治疗方法的有效性需要通过随机试验进行验证.
研究的目的:
- 为了评估双极血静与标准治疗相比,双极血静的优越性,用于主动NVUGIB的初级内镜治疗.
- 评估成功的初级血液静止和30天内没有复发出血的结合终点.
主要方法:
- 一个前性的,随机的,多中心的优越性试验,比较双极血静止 (实验性疗法) 与标准疗法.
- 有活跃NVUGIB的患者将被随机分配1:1. 在初始治疗失败的情况下,允许交叉和救援治疗.
- 每个手臂的样本大小为45名患者,计算以检测25.4%的绝对差异,80%的功率和0.05的显著程度.
主要成果:
- 本部分应在研究完成并获得结果后填写.
结论:
- 这项研究假设双极血静止将在NVUGIB的标准治疗中表现出优越的疗效.
- 随机化的伦理理由是基于这两种干预措施的批准状态.
- 研究设计包括安全措施,如交叉和救援治疗,并考虑潜在的混因素,如抗凝剂使用.
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