Liver Stiffness Measurement (LSM) in Predicting Progress of Liver Fibrosis After TACE for Hepatocellular Carcinoma

Study Overview
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Brief Summary
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Objective: To evaluate the efficacy of preoperative liver stiffness measurement(LSM) by FibroScan in predicting the progress of liver fibrosis and prognosis after transcatheter arterial chemoembolization (TACE) in hepatocellular carcinoma (HCC). Background: Progress of liver fibrosis and liver failure and related poor prognosis after TACE which are not completely predictable by current method including Child-Pugh Classification. LSM is used to calculate the degree of liver fibrosis and is affected by several liver injury, e.g. elevated Alanine aminotransferase（ALT）, Aspartate transaminase(AST) and Bilirubin et al. The investigators assume that LSM could be use to predict progress of liver fibrosis and adverse effects after TACE in HCC. Methods: At least 200 patients will be recruited in this prospective observational study with preoperative LSM, demographic, laboratory, radiological and other treatment-related factors. Participants will be followed up till death or to the end of study no matter the liver failure occurs or not. Data will be analyzed to build a mathematical predicting model. Research hypothesis：TACE is related to progress of liver fibrosis and a mathematical model with LSM is able to predict the risk of liver failure and prognosis in HCC.

Official Title
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Value of Liver Stiffness Measurement (LSM) in Predicting the Progress of Liver Fibrosis After Transcatheter Arterial Chemoembolization (TACE) for Hepatocellular Carcinoma, an Observational Study

Conditions
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Hepatocellular Carcinoma, Liver Failure

Intervention / Treatment
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* Procedure: TACE


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age：18-80 HCC diagnosed by pathologist or physician according to Guidelines Chronic Hepatitis B (CHB) background receive at least 1 TACE volunteer to join the research Exclusion Criteria: massive lesion with insufficient liver left for LSM examination associated with other liver diseases: Chronic Hepatitis C(CHC),Autoimmune Hepatitis(AIH),Wilson's disease. severe obesity(BMI>28) pregnancy other inappropriate situation defined by investigators.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| HCC received TACE<br>observational study set only one group with HCC received TACE | Procedure: TACE<br>* transcatheter arterial chemoembolization<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change of LSM(kpa) measured by FibroScan(a kind of external harmless ultrasonoscope) | The investigators will investigate the value of LSM( kpa) by machine of FibroScan ( produced by France Echo). The investigators will record LSMs before and after each procedure of TACE. The investigators will calculate the change of LSMs of each participants. | within 1 week pre-TACE and 1 week post-TACE |