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

Liver Fibrosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03386890
• Other study ID #: XMLX201606
• Status: Recruiting
• Phase: N/A
• First received: December 6, 2017
• Last updated: December 28, 2017
• Start date: December 2015
• Est. completion date: December 31, 2018

Study information

• Verified date: December 2017
• Source: Beijing Friendship Hospital
• Contact: Qianyi Wang
• Phone: 86-13811629824
• Email: wangqy1001[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Fatty Liver
• Fibrosis
• Liver Cirrhosis
• Liver Diseases
• Liver Fibrosis
• Liver Steatosis
• Non-alcoholic Fatty Liver Disease
• Nonalcoholic Fatty Liver Disease

Locations

Country	Name	City	State
China	Beijing Friendship Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Friendship Hospital

Country where clinical trial is conducted

China, 

Outcome

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