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慢性亚皮血瘤治疗与栓塞与手术研究 (CHESS):试验理由和协议
Manisha Koneru1, Ajith J Thomas1, Farhan Siddiq2
1Department of Neurosurgery, Cooper University Health Care, Camden, NJ, USA.
概括
该CHESS试验将独立的中脑膜动脉栓塞 (MMAE) 与慢性腹腔内血瘤 (CSDH) 的手术进行比较. 本研究旨在确定MMAE作为安全有效的CSDH独立治疗方法.
科学领域:
- 神经外科 神经外科
- 干预性神经辐射学
- 临床试验 临床试验
背景情况:
- 慢性亚皮血瘤 (CSDH) 通常通过药物或手术进行管理.
- 中脑膜动脉栓塞 (MMAE) 显示出减少CSDH复发和需要救援手术的希望.
- 在CSDH治疗中缺乏独立MMAE随机对照试验数据.
研究的目的:
- 为了比较独立的MMAE与用于治疗中度症状的CSDH的常规手术.
- 评估MMAE作为独立的CSDH治疗的安全性和有效性.
- 为推进CSDH管理中的内血管方法提供数据.
主要方法:
- 未来的,多中心的,开放标签的随机对照试验 (CHESS研究).
- 随机化CSDH患者1:1进行传统手术或独立MMAE.
- 180天的随访期来评估结果.
主要成果:
- 主要终点:复合的救援手术和/或死亡180天内.
- 评估的安全结果:缺血性中风,不良事件,神经状态,发作,脑神经病变.
- 探索性终点:血瘤体积减少,功能结果,生活质量,认知,头痛严重程度.
结论:
- CHESS是第一个评估独立MMAE与中度CSDH常规手术的RCT.
- 结果将告知内血管技术在CSDH治疗中的作用.
- 这项试验解决了在CSDH管理中MMAE证据的关键缺口.
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