A Study of HCC High Risk Group Using Two Surveillance Tools

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

COMPLETED

Total Enrollment

139 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-11-28

Study Completion Date

2019-10-01

Brief Summary

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The purpose of this study is to compare sensitivity for hepatocellular carcinoma (HCC) of bi-annual ultrasonography and low dose computed tomography (LDCT) in patients at high risk of HCC.

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Detailed Description

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Patients at high risk of HCC are recommended to undergo biannual surveillance using ultrasound. In this study, LDCT is performed in addition to biannual ultrasound surveillance in eligible patients to compare their sensitivity for HCC. Standard of reference would be follow-up imaging and/or gadoxetic acid-enhanced liver MRI.

Conditions

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HCC

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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High risk group of HCC

known high risk group of HCC according to AASLD guideline. And patients whose risk index is equal to or higher than 2.33.

Risk Index = 1.65 (if the prothrombin activity is \<=75%) + 1.41 (if the age is 50 years or older) + 0.92 (if the platelet count is \<=100x10(3)/mm3) + 0.74 (if the presence of anti-hepatitis C virus \[HCV\] or hepatitis B surface antigen \[HBsAg\] is positive).

Patients undergo ultrasonography and LDCT using non-ionic monomer iodinated CT contrast media biannually and the interval between ultrasound and LDCT is within 30 days.

non-ionic monomer iodinated CT contrast media

Intervention Type DRUG

patients underwent contrast-enhanced CT using aforementioned CT contrast media (non-ionic monomer iodinated CT contrast media)

Interventions

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non-ionic monomer iodinated CT contrast media

patients underwent contrast-enhanced CT using aforementioned CT contrast media (non-ionic monomer iodinated CT contrast media)

Intervention Type DRUG

Other Intervention Names

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contrast enhanced CT

Eligibility Criteria

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Inclusion Criteria

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* \> 20 years
* high risk group of HCC according to AASLD guideline
* risk index \> = 2.33
* currently on regular biannual surveillance using ultrasonography
* sign informed consent

Exclusion Criteria

Patients with any of following condition cannot be enrolled.

* previously diagnosed with HCC
* any contraindication of contrast enhanced CT including allergic reaction to iodine
* history of other malignancy

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No