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

NCT ID: NCT03285867

Last Updated: 2018-04-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-06-25

Study Completion Date

2021-12-31

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.

Detailed Description

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Conditions

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Hepatocellular Carcinoma Liver Failure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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HCC received TACE

observational study set only one group with HCC received TACE

TACE

Intervention Type PROCEDURE

transcatheter arterial chemoembolization

Interventions

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TACE

transcatheter arterial chemoembolization

Intervention Type PROCEDURE

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nanfang Hospital, Southern Medical University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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wang kunyuan

Role: CONTACT

Phone: 0086-020-62787430

Email: [email protected]

liu hongyan

Role: CONTACT

Phone: 0086-020-62787631

Email: [email protected]

Other Identifiers

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liuhy

Identifier Type: -

Identifier Source: org_study_id