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

Hepatocellular Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03285867
• Other study ID #: liuhy
• Status: Not yet recruiting
• Start date: June 25, 2018
• Est. completion date: December 2021

Study information

• Verified date: April 2018
• Source: Nanfang Hospital of Southern Medical University
• Contact: wang kunyuan
• Phone: 0086-020-62787430
• Email: 390671613[@]qq.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: December 2021
• Est. primary completion date: June 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma
• Liver Cirrhosis
• Liver Failure

Intervention

Procedure:
• TACE
transcatheter arterial chemoembolization

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Nanfang Hospital of Southern Medical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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