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Trial record 26 of 1393 for:    bilirubin AND alanine

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03285867
Recruitment Status : Not yet recruiting
First Posted : September 18, 2017
Last Update Posted : April 30, 2018
Information provided by (Responsible Party):
Nanfang Hospital of Southern Medical University

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.

Condition or disease Intervention/treatment
Hepatocellular Carcinoma Liver Failure Procedure: TACE

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Group/Cohort Intervention/treatment
HCC received TACE
observational study set only one group with HCC received TACE
Procedure: TACE
transcatheter arterial chemoembolization

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients admitted to our department

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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT03285867

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Contact: wang kunyuan 0086-020-62787430
Contact: liu hongyan 0086-020-62787631

Sponsors and Collaborators
Nanfang Hospital of Southern Medical University

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Responsible Party: Nanfang Hospital of Southern Medical University Identifier: NCT03285867     History of Changes
Other Study ID Numbers: liuhy
First Posted: September 18, 2017    Key Record Dates
Last Update Posted: April 30, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Carcinoma, Hepatocellular
Liver Failure
Hepatic Insufficiency
Liver Cirrhosis
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases