Risk Prediction of Bleeding in Liver Cirrhosis by Combi-elastography
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Spleen stiffness
研究概览
简要总结
Through the parameters of liver stiffness and spleen stiffness obtained by combi-elastography technique, summarize and analyze the warning index of esophagogastric variceal bleeding in patients with cirrhosis, so as to provide a new and valuable technique for clinical diagnosis.
详细描述
Firstly,the combi-elastography technique developed by HITACHI uses the method of multi-index and multi-parameter to evaluate the liver stiffness and spleen stiffness comprehensively.
And then,this prospective study is designed to follow up patients with cirrhosis for a period of 12 months, summarize and analyze the warning index of bleeding in patients with cirrhosis,so as to provide a new and valuable technique for clinical diagnosis.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-80 years old, no gender limit;
- •The clinical diagnosis is in line with patients with liver cirrhosis caused by chronic hepatitis B, and the gastroscopy is in line with the indications of portal hypertension;
- •Gastroscopy needs to provide the degree of gastroesophageal varices;
- •Sign the informed consent form.
排除标准
- •Patients with cirrhosis and portal hypertension because of other causes or combined with other causes(such as viral hepatitis other than hepatitis B,Autoimmune liver disease, alcoholic liver disease, metabolism-related fatty liver disease, etc.)
- •Patients with a history of spleen-related operations, such as splenectomy, splenic embolism;
- •Patients undergoing portosystemic shunt or TIPS;
- •Isolated esophageal venous tumor and its bleeding patients;
- •History of upper gastrointestinal tumor or bleeding from gastric ulcer , etc;
- •Those with serious diseases of other systems that cannot cooperate with elastography examination, such as heart failure, renal failure, mental illness, etc;
- •Ascites before liver and spleen result unable to complete elasticity examination;
- •Pregnant patients.
结局指标
主要结局
Spleen stiffness
时间窗: baseline
Spleen stiffness can be available by ultrasound elastography checking.
F index
时间窗: baseline
F index is linked to the degree of liver fibrosis,and it can be available by ultrasound elastography checking.
A index
时间窗: baseline
A index is linked to the degree of hepatitis ,and it can be available by ultrasound elastography checking.
次要结局
未报告次要终点
研究者
Ping Liang
Chief physician
Chinese PLA General Hospital