Liver Stiffness Measurement (LSM) in Predicting Progress of Liver Fibrosis After TACE for Hepatocellular Carcinoma
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|ClinicalTrials.gov Identifier: NCT03285867|
Recruitment Status : Not yet recruiting
First Posted : September 18, 2017
Last Update Posted : April 30, 2018
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.
|Condition or disease||Intervention/treatment|
|Hepatocellular Carcinoma Liver Failure||Procedure: TACE|
|Study Type :||Observational|
|Estimated Enrollment :||200 participants|
|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|
|Estimated Study Start Date :||June 25, 2018|
|Estimated Primary Completion Date :||June 2021|
|Estimated Study Completion Date :||December 2021|
HCC received TACE
observational study set only one group with HCC received TACE
transcatheter arterial chemoembolization
- The change of LSM(kpa) measured by FibroScan(a kind of external harmless ultrasonoscope) [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03285867
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