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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03386890
Enrollment
400
Registered
2017-12-29
Start date
2015-12-31
Completion date
2018-12-31
Last updated
2017-12-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver Fibrosis, Liver Steatosis, Nonalcoholic Fatty Liver Disease

Keywords

Non-invasive Assessment, Transient Elastography, Controlled Attenuation Parameter

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.

Interventions

None listed

Sponsors

Beijing Friendship Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Liver Biopsy1 yearliver histological section
CAP1 yearControlled Attenuation Parameter
TE1 yearTransient Elastography

Secondary

MeasureTime frameDescription
electrolyte1 yearelectrolyte
blood glucose1 yearblood glucose
Blood routine test1 yearBlood routine test
uric acid1 yearuric acid
kidney function test1 yearkidney function test
blood lipid1 yearblood lipid
liver biochemistry test1 yearliver biochemistry test
abdominal ultrasound1 yearabdominal ultrasound

Countries

China

Contacts

Primary ContactQianyi Wang
wangqy1001@hotmail.com86-13811629824

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 1, 2026