A Novel Approach for Transjugular Intrahepatic Portocaval Shunt Creation Using Real-time Three Dimensional Roadmap
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Technical success rate
研究概览
简要总结
TIPS creation has been widely used to treat the complications associated with portal hypertension. In association with increased operator experience and the ongoing development of imaging modalities, the rate of major complications associated with TIPS has decreased significantly in the past decades. However, the passage of a curved needle from the hepatic vein into the portal vein still remains a challenging and time-consuming part of the procedure and is associated with puncture-related complications that are potentially fatal.Three-dimensional roadmap guidance has been widely applied in various interventions. The aim of the present study is to prospectively assess the feasibility and efficacy of real-time 3D roadmap guidance during TIPS creation.
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
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •cirrhosis complications of portal hypertension requiring TIPS
排除标准
- •non-cirrhotic portal hypertension complete occlusion of intrahepatic portal vein gastro-renal shunt presence of liver tumor pregnancy other contradictions of TIPS
研究组 & 干预措施
conventional TIPS
conventional TIPS procedure using wedged hepatic venography
干预措施: conventional TIPS procedure (Other)
3D roadmap
TIPS was established using 3d roadmap guidance
干预措施: 3d roadmap guidance (Other)
结局指标
主要结局
Technical success rate
时间窗: 1 month
number of patients who have received TIPS creation technically successfully
number of punctures
时间窗: 1 month
number of intrahepatic punctures for TIPS creation
次要结局
- radiographic fluoroscopy time for portal vein entry(1 month)
- radiographic fluoroscopy time for the whole procedure(1 month)
- procedural time(1 month)
研究者
luo xuefeng
attending doctor
West China Hospital