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

NCT ID: NCT03386890

Last Updated: 2017-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-12-31

Study Completion Date

2018-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Nonalcoholic Fatty Liver Disease Liver Steatosis Liver Fibrosis

Keywords

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Non-invasive Assessment Transient Elastography Controlled Attenuation Parameter

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing Friendship Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jidong Jia

Chief Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Beijing Friendship Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Qianyi Wang

Role: CONTACT

Phone: 86-13811629824

Email: [email protected]

Facility Contacts

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Qianyi Wang

Role: primary

References

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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.

Reference Type DERIVED
PMID: 39152361 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31559605 (View on PubMed)

Other Identifiers

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XMLX201606

Identifier Type: -

Identifier Source: org_study_id