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Status unknownNCT03285867Updated Apr 30, 2018

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

An observational study in Hepatocellular Carcinoma and Liver Failure, sponsored by Nanfang Hospital, Southern Medical University. Status unknown. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2018-04-30.

Sponsored by Nanfang Hospital, Southern Medical University · Observational

The sponsor has not verified this record recently (last verified Apr 2018), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
200
Ages
18 Years to 80 Years
Sex
All
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Study 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.

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Conditions studied

03

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
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

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.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
200 participants (estimated)
Patient registry
No

Groups and cohorts

  • HCC received TACE

    observational study set only one group with HCC received TACE

    Procedure: TACE

Interventions

  • ProcedureTACE

    transcatheter arterial chemoembolization

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What researchers measure

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.

    Time frame: within 1 week pre-TACE and 1 week post-TACE

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03285867
Lead sponsor
Nanfang Hospital, Southern Medical University
Responsible party
Sponsor
First posted
Sep 18, 2017
Start date
Jun 25, 2018 (estimated)
Primary completion
Jun 2021 (estimated)
Completion
Dec 2021 (estimated)
Last update
Apr 30, 2018

Study contacts

wang kunyuan
Contact
390671613@qq.com
0086-020-62787430
liu hongyan
Contact
liuhongyan205628@163.com
0086-020-62787631

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.

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