治疗常见胆道结石的最小内切除术与内切除术 (MARBLE试验):多中心随机对照试验的研究方案
Tadahisa Inoue1, Akinori Maruta2, Junichi Kaneko3
1Department of Gastroenterology, Aichi Medical University, Aichi, Japan. tinoue-tag@umin.ac.jp.
Trials
|August 27, 2025
概括
这项随机试验将最小内切除术与气球扩张 (ESBD) 与常见胆道结石的标准内切除术 (EST) 进行比较. 结果将决定ESBD是否提供更安全,更有效的治疗选择.
科学领域:
- 胃肠病学
- 透视外科手术
- 胆道干预
背景情况:
- 常见的胆管结石 (CBDS) 通常是通过内透镜 (EST) 或内透镜乳头气球扩张 (EPBD) 来治疗的.
- EST带有出血和穿孔的风险;EPBD的术后胰腺炎率很高.
- 用气球扩张进行内切除术 (ESBD) 是一种旨在降低这些风险的新方法.
研究的目的:
- 预期评估ESBD与EST治疗小常见胆道结石的疗效和安全性.
- 确定ESBD是否可以作为一种新的标准治疗选择.
主要方法:
- 一个多中心的,随机的,开放的,平行组试验比较ESBD和EST对CBDS治疗.
- 患者被随机分配 (1:1) 给ESBD (最小切口随后扩张) 或EST (中等切口).
- 主要终点:与手术相关的不良事件发生率 (胰腺炎,出血,穿孔);次要终点包括成功率和手术时间.
主要成果:
- 这个部分在提供的摘要中没有.
结论:
- 这是第一个针对小CBDS进行前性ESBD评估的多中心随机对照试验.
- 结果将澄清ESBD与传统EST的比较安全性和有效性.
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