Clinical Application of Non-invasive Assessment for Staging Liver Steatosis and Liver Fibrosis
试验速览
- 阶段
- 不适用
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- CAP
研究概览
简要总结
Nowadays, the morbidity of Nonalcoholic fatty liver disease (NAFLD) show ascending trend year by year, which has become an important public health problem in China. As NAFLD can progress to Non-alcoholic steatohepatitis (NASH), cirrhosis and Hepatocarcinoma, the identification and quantitative evaluation of liver steatosis and its dynamic changes are crucial. While liver biopsy is still the gold standard in the diagnosis of NAFLD, its application is limited because of the invasive procedure.The Transient Elastography(TE) combined with the Controlled Attenuation Parameter(CAP) is a new non-invasive diagnostic method for fatty liver and liver fibrosis.
In order to evaluate the diagnostic value of non-invasive assessment for the degree of liver steatosis and staging liver fibrosis, this non-invasive method will be assessed by the golden standard of liver biopsy among 400 NAFLD patients.The treatment protocols will be decided by doctor and patient both (treatment protocols and medicine are not required). Blood routine, blood biochemistry, abdominal ultrasound and Transient Elastography(TE) combined with the Controlled Attenuation Parameter(CAP) are detected during the follow-up.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age:18≤,≥65
- •Gender:male or female
- •NAFLD patient,agree with the paracentesis of liver tissue
- •Regular follow-up
- •Signing the Informed Consent Form
排除标准
- •Hepatic decompensation：Including cirrhotic complications,such as ascites,hepatic encephalopathy,digestive tract bleeding,hepatorenal syndrome,spontaneous bacterial peritonitis,and HCC.
- •Complications of HBV,HCV,HIV.Complications of alcoholic liver disease,autoimmune liver disease,hereditary metabolic liver disease, drug-induced liver disease and other chronic liver disease.
- •AFP>100ng/ml and imaging indicates malignant occupying.Or AFP still>100ng/ml within 3 months.
- •Creatinine was 1.5 times higher than the upper limit of the normal value.
- •Combined with other malignant tumors(except those cured).
- •Serious diseases of heart, lung, kidney, brain, blood and other important organs with dysfunction.
- •severe neurological and psychiatric diseases (such as epilepsy, depression, mania, schizophrenia, etc.)
- •Pregnant women and breast-feeding women.
- •The researchers consider that it is not suitable for the patients to participate in this study.
结局指标
主要结局
CAP
时间窗: 1 year
Controlled Attenuation Parameter
TE
时间窗: 1 year
Transient Elastography
Liver Biopsy
时间窗: 1 year
liver histological section
次要结局
- kidney function test(1 year)
- electrolyte(1 year)
- Blood routine test(1 year)
- blood glucose(1 year)
- blood lipid(1 year)
- liver biochemistry test(1 year)
- abdominal ultrasound(1 year)
- uric acid(1 year)
研究者
Jidong Jia
Chief Physician
Beijing Friendship Hospital