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

NCT03285867 | Unknown

• 1 other identifier: liuhy
• Study Type: observational
• Target: 200
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hepatocellular Carcinoma; Liver Failure

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

HCC received TACE

observational study set only one group with HCC received TACE

Procedure: TACE

Interventions

TACE PROCEDURE

transcatheter arterial chemoembolization

HCC received TACE

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients admitted to our department

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University: lead

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Liver Failure

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases; Hepatic Insufficiency

Central Study Contacts

wang kunyuan

CONTACT

0086-020-62787430; 390671613@qq.com

liu hongyan

CONTACT

0086-020-62787631; liuhongyan205628@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2017
• First Posted: September 18, 2017
• Study Start: June 25, 2018
• Primary Completion: June 1, 2021
• Study Completion: December 1, 2021
• Last Updated: April 30, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share