A Pilot Study Aiming to Assess the Feasibility of Critical Flicker Frequency for the Diagnosis of Minimal Encephalopathy in Patients With Cirrhosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- success rate of Critical Flicker Frequency (CFF) Procedure
研究概览
简要总结
All patients eligible for TIPS (Transjugular intrahepatic portosystemic shunt) procedure will be considered for inclusion. After written inform consent, psychometric tests in order to calculate the psychometric hepatic encephalopathy (PHES) score, the gold standard for the diagnosis of minimal encephalopathy and critical flicker frequency (CFF) will be performed before the TIPS procedure. After TIPS, patients will be followed during one year and the psychometric test and CFF will be performed every 3 months.
30 patients will be included.
The main endpoint is the success rate of CFF. The secondary end points are
- Correlation between CFF and PHES score
- Performance of CFF and PHES score to predict the occurrence of overt encephalopathy after TIPS procedure
- A sample collection during TIPS procedure is also performed for validation of biomarkers
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with cirrhosis in whom a TIPS is indicated
- •patients have given their informed consent te be included
排除标准
- •pregnant women
- •patients who cannot see the red color
- •refusal to participate
结局指标
主要结局
success rate of Critical Flicker Frequency (CFF) Procedure
时间窗: before TIPS and every 3 months till one year
number of patients in whom ten measurement will be available / 30 patients
次要结局
- occurrence of encephalopathy(every 3 months till one year after TIPS procedure)