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

• Conditions: Liver Failure; Hepatocellular Carcinoma
• Interventions: Procedure: TACE

• Registration Number: NCT03285867
• Lead Sponsor: Nanfang Hospital, Southern Medical University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-08-27
• Study First Submitted QC: 2017-09-13
• Study First Posted: 2017-09-18
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-27
• Last Update Posted: 2018-04-30
• Study Start: 2018-06-25
• Primary Completion: 2021-06
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
HCC received TACE	TACE	observational study set only one group with HCC received TACE

Primary Outcome Measures

Name	Time	Method
The change of LSM(kpa) measured by FibroScan(a kind of external harmless ultrasonoscope)	within 1 week pre-TACE and 1 week post-TACE	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.