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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03386890
Other study ID # XMLX201606
Secondary ID
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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