Clinical Application of Non-invasive Assessment for Staging Liver Steatosis and Liver Fibrosis

Study Overview
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Brief Summary
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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.

Official Title
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Clinical Application of Non-invasive Assessment for Staging Liver Steatosis and Liver Fibrosis

Conditions
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Nonalcoholic Fatty Liver Disease, Liver Steatosis, Liver Fibrosis

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age:18≤,≥65 Gender:male or female NAFLD patient,agree with the paracentesis of liver tissue Regular follow-up Signing the Informed Consent Form Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Liver Biopsy | liver histological section | 1 year | 
| CAP | Controlled Attenuation Parameter | 1 year | 
| TE | Transient Elastography | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood routine test | Blood routine test | 1 year | 
| liver biochemistry test | liver biochemistry test | 1 year | 
| abdominal ultrasound | abdominal ultrasound | 1 year | 
| electrolyte | electrolyte | 1 year | 
| blood glucose | blood glucose | 1 year | 
| blood lipid | blood lipid | 1 year | 
| uric acid | uric acid | 1 year | 
| kidney function test | kidney function test | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Non-invasive Assessment, Transient Elastography, Controlled Attenuation Parameter