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.

Study Overview

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

• Study Type: Observational
• Enrollment (Anticipated): 400

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100000
      • Recruiting
      • Beijing Friendship Hospital
      • Contact: Qianyi Wang; Phone Number: 86-13811629824; Email: wangqy1001@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Beijing Friendship Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: December 1, 2015
• Primary Completion (Anticipated): December 31, 2018
• Study Completion (Anticipated): December 31, 2018

Study Registration Dates

• First Submitted: December 6, 2017
• First Submitted That Met QC Criteria: December 28, 2017
• First Posted (Actual): December 29, 2017

Study Record Updates

• Last Update Posted (Actual): December 29, 2017
• Last Update Submitted That Met QC Criteria: December 28, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: Transient Elastography; Controlled Attenuation Parameter; Non-invasive Assessment
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Liver Diseases; Fibrosis; Fatty Liver; Liver Cirrhosis; Non-alcoholic Fatty Liver Disease
• Other Study ID Numbers: XMLX201606

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No