Clinical trial NCT03386890: Clinical Application of Non-invasive Assessment for Staging Liver Steatosis and Liver Fibrosis
Official title: Clinical Application of Non-invasive Assessment for Staging Liver Steatosis and Liver Fibrosis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Nonalcoholic Fatty Liver Disease
Liver Steatosis
Liver Fibrosis
Keywords: Non-invasive Assessment
Transient Elastography
Controlled Attenuation Parameter
Lead sponsor: Beijing Friendship Hospital
Sponsor class: OTHER
First posted: 2017-12-29
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: NAFLD male or female patints from 18 to 65 years old,who agree with the paracentesis of liver tissue and agree to sign the informed consent form.They are accessible for regular follow-up.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Liver Biopsy
timeFrame: 1 year
measure: CAP
timeFrame: 1 year
measure: TE
timeFrame: 1 year
Secondary outcomes:
measure: Blood routine test
timeFrame: 1 year
measure: liver biochemistry test
timeFrame: 1 year
measure: abdominal ultrasound
timeFrame: 1 year
measure: electrolyte
timeFrame: 1 year
measure: blood glucose
timeFrame: 1 year
measure: blood lipid
timeFrame: 1 year
measure: uric acid
timeFrame: 1 year
measure: kidney function test
timeFrame: 1 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Friendship Hospital
state: Beijing
Study officials:
References:
citation: Wang Q, You H, Ou X, Zhao X, Sun Y, Wang M, Wang P, Wang Y, Duan W, Wang X, Wu S, Kong Y, Saxena R, Gouw ASH, Jia J. Non-obese histologically confirmed NASH patients with abnormal liver biochemistry have more advanced fibrosis. Hepatol Int. 2019 Nov;13(6):766-776. doi: 10.1007/s12072-019-09982-z. Epub 2019 Sep 26.