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

Nanfang Hospital, Southern Medical University

Status: Unknown

Conditions: Liver Failure; Hepatocellular Carcinoma

Treatments: Procedure: TACE

Study type: Observational

Funder types: Other

Identifiers

NCT03285867

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Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

200 participants in 1 patient group

HCC received TACE

Description:

observational study set only one group with HCC received TACE

Treatment:

Procedure: TACE