NCT05363345招募中不适用
Randomized Trial of the Removal Ability With Vortic Catch V Basket Catheter Versus Ordinary Basket Catheter for Bile Duct Stones
Akira Horiuchi1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2022年2月2日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Percentage of stones cleared
研究概览
简要总结
Investigators will perform randomized trial of the removal ability with Vortic Catch V basket catheter versus ordinary basket catheter for bile duct stones (≧ 10 mm).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with suspected of having, or known to have, common bile duct stones (≧ 10 mm)
- •endoscopic papillary balloon dilation (EPLBD) was performed.
排除标准
- •septic shock
- •coagulopathy (international normalized ratio 1.3, partial thromboplastin time greater than twice that of control),
- •<platelet count 50,000 / L
- •suspected or confirmed malignancy
研究组 & 干预措施
Vortic Catch V basket catheter
Experimental
Common bile duct stones (≧ 10 mm) are removed by using Vortic Catch V basket catheter following endoscopic papillary large balloon dilation.
干预措施: bile duct stone removal (Device)
ordinary basket catheter
Active Comparator
Common bile duct stones (≧ 10 mm) are removed by using ordinary basket catheter following endoscopic papillary large balloon dilation.
干预措施: bile duct stone removal (Device)
结局指标
主要结局
Percentage of stones cleared
时间窗: Procedure time
Percentage of stones cleared is evaluated after the completion of procedure.
次要结局
- Total procedural time(Procedure time)
- the number of adverse events(Procedure time)
- the numbers of morbidities and mortality(30 days)
研究者
Akira Horiuchi
Chief of Digestive Disease Center
Showa Inan General Hospital
研究点 (1)
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