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

• Conditions: Nonalcoholic Fatty Liver Disease; Liver Steatosis; Liver Fibrosis

• Registration Number: NCT03386890
• Lead Sponsor: Beijing Friendship Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-12
• Status Verified: 2017-12
• Study First Submitted: 2017-12-06
• Study First Submitted QC: 2017-12-28
• Last Update Submitted: 2017-12-28
• Study First Posted: 2017-12-29
• Last Update Posted: 2017-12-29
• Primary Completion: 2018-12-31
• Study Completion: 2018-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 400

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
CAP	1 year	Controlled Attenuation Parameter
TE	1 year	Transient Elastography
Liver Biopsy	1 year	liver histological section

Secondary Outcome Measures

Name	Time	Method
liver biochemistry test	1 year	liver biochemistry test
abdominal ultrasound	1 year	abdominal ultrasound
uric acid	1 year	uric acid
kidney function test	1 year	kidney function test
electrolyte	1 year	electrolyte
Blood routine test	1 year	Blood routine test
blood glucose	1 year	blood glucose
blood lipid	1 year	blood lipid

Trial Locations

Locations (1)

Beijing Friendship Hospital; 🇨🇳 Beijing, Beijing, China