Liver Fibrosis Clinical Trial
Official title:
Clinical Application of Non-invasive Assessment for Staging Liver Steatosis and Liver Fibrosis
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.
Status | Recruiting |
Enrollment | 400 |
Est. completion date | December 31, 2018 |
Est. primary completion date | December 31, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
China | Beijing Friendship Hospital | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
Beijing Friendship Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Liver Biopsy | liver histological section | 1 year | |
Primary | CAP | Controlled Attenuation Parameter | 1 year | |
Primary | TE | Transient Elastography | 1 year | |
Secondary | Blood routine test | Blood routine test | 1 year | |
Secondary | liver biochemistry test | liver biochemistry test | 1 year | |
Secondary | abdominal ultrasound | abdominal ultrasound | 1 year | |
Secondary | electrolyte | electrolyte | 1 year | |
Secondary | blood glucose | blood glucose | 1 year | |
Secondary | blood lipid | blood lipid | 1 year | |
Secondary | uric acid | uric acid | 1 year | |
Secondary | kidney function test | kidney function test | 1 year |
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