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

NCT03386890 | Unknown

• 1 other identifier: XMLX201606
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Nonalcoholic Fatty Liver Disease; Liver Steatosis; Liver Fibrosis

Keywords

Non-invasive Assessment; Transient Elastography; Controlled Attenuation Parameter

Outcome Measures

Primary Outcomes (3)

• Liver Biopsy

  liver histological section

  1 year

• CAP

  Controlled Attenuation Parameter

  1 year

• TE

  Transient Elastography

  1 year

Secondary Outcomes (8)

• Blood routine test

  1 year

• liver biochemistry test

  1 year

• abdominal ultrasound

  1 year

• electrolyte

  1 year

• blood glucose

  1 year

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Age:18≤,≥65
• Gender:male or female
• NAFLD patient,agree with the paracentesis of liver tissue
• Regular follow-up
• Signing the Informed Consent Form

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Friendship Hospital: lead

Study Sites (1)

Beijing Friendship Hospital

Beijing, Beijing Municipality, 100000, China

RECRUITING

Related Publications (2)

• Tong X, Sun Y, Wang Q, Zhao X, Chen W, Zhang M, Ren Y, Zhao X, Wu X, Zhao J, Sun C, Zheng M, Ren H, Yang Z, Ou X, Jia J, You H. Delicate and thin fibrous septa indicate a regression tendency in metabolic dysfunction-associated steatohepatitis patients with advanced fibrosis. Hepatol Int. 2025 Feb;19(1):166-180. doi: 10.1007/s12072-024-10719-w. Epub 2024 Aug 16.

  PMID: 39152361 DERIVED

• 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.

  PMID: 31559605 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

liver histological section

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Fatty Liver; Liver Cirrhosis

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Qianyi Wang

CONTACT

86-13811629824; wangqy1001@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: December 6, 2017
• First Posted: December 29, 2017
• Study Start: December 1, 2015
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: December 29, 2017

Record last verified: 2017-12

Locations

CN (1)