NCT02480426Unknown不适用
Guidance for TIPS Creation: CT-image Versus CO2 Portography
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 入组人数
- 15
- 主要终点
- Technical success rate
研究概览
简要总结
To prospectively evaluate the efficacy of real-time 3D CT-image guidance and CO2 portography during transjugular intrahepatic portosystemic shunt (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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Scheduled for indicated TIPS procedure
排除标准
- •Presence of portal vein thrombosis
- •Presence of ascites
- •Presence of hepatic vein occlusion or stenosis
- •Proven malignancy including hepatocellular carcinoma
- •End-stage renal disease under renal replacement therapy;
- •Cardiorespiratory failure
- •Pregnancy or patients not giving informed consent for TIPS procedures
研究组 & 干预措施
CT-image guidance
Experimental
Previously acquired portal venous phase of CT datasets and intra-operative CT datasets were registered on a dedicated workstation. The selected volume of interest of the CT-image showing portal vein vasculature was overlaid onto the fluoroscopic display as real-time 3D CT-image guidance during the procedure.
干预措施: CT-image guidance (Device)
CO2 portography
Active Comparator
two two-dimensional (2D) CO2 portograms
干预措施: CO2 portograms guidance (Drug)
结局指标
主要结局
Technical success rate
时间窗: procedure
次要结局
- Median needle passes for portal vein entry(procedure)
- The median radiation dose for the whole TIPS procedure(procedure)
- The rate of TIPS complication(6 months)
- Median radiographic fluoroscopy time for portal vein entry(procedure)
研究者
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