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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03285867
Other study ID # liuhy
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design


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
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