The Effect of Viral Load on Intrahepatic Recurrence in Hepatitis B Virus (HBV)-Related Hepatocellular Carcinoma (HCC)

NCT ID: NCT00397540

Last Updated: 2019-03-18

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

145 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-10-31

Study Completion Date

2011-05-31

Brief Summary

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The purpose of this study is to evaluate the effect of serum hepatitis B virus (HBV) DNA level on intrahepatic recurrence in locally treatable hepatocellular carcinomas (HCCs) related with HBV.

Detailed Description

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Prospective cohort study

Survival

* Overall survival rate
* Disease free survival rate

Recurrence

* Cumulative recurrence rate

Conditions

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Carcinoma, Hepatocellular Chronic Hepatitis B

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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percutaneous ethanol injection therapy

Patients with hepatocellular carcinoma who will be treated with PEIT (percutaneous ethanol injection therapy)

Group Type ACTIVE_COMPARATOR

PEIT

Intervention Type PROCEDURE

Percutaneous Ethanol Injection Therapy

radiofrequency thermal ablation

Patients with hepatocellular carcinoma who will be treated with RFTA (radiofrequency thermal ablation)

Group Type ACTIVE_COMPARATOR

RFTA

Intervention Type PROCEDURE

Radiofrequency Thermal Ablation

Interventions

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PEIT

Percutaneous Ethanol Injection Therapy

Intervention Type PROCEDURE

RFTA

Radiofrequency Thermal Ablation

Intervention Type PROCEDURE

Other Intervention Names

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PEI, local ablation therapy RFA, local ablation therapy

Eligibility Criteria

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Inclusion Criteria

* Child-Pugh Class A or B
* Maximal tumor size less than 5 cm
* No previous history of treatment for hepatocellular carcinoma
* Recurrent hepatocellular carcinoma located more than 2 cm from the previous cancer site and is found more than 1 year's gap

Exclusion Criteria

* Hepatocellular carcinoma in portal vein
* Hepatocellular carcinoma in hepatic vein
Minimum Eligible Age

19 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jung-Hwan Yoon

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Won Kim, Professor

Role: STUDY_DIRECTOR

Seoul National University Hospital

Locations

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Seoul National University Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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Seo JY, Kim W, Kwon JH, Jin EH, Yu SJ, Kim HY, Jung YJ, Kim D, Kim YJ, Yoon JH, Lee HS. Noninvasive fibrosis indices predict intrahepatic distant recurrence of hepatitis B-related hepatocellular carcinoma following radiofrequency ablation. Liver Int. 2013 Jul;33(6):884-93. doi: 10.1111/liv.12132. Epub 2013 Mar 5.

Reference Type DERIVED
PMID: 23461618 (View on PubMed)

Chung GE, Kim W, Lee JH, Kim YJ, Yoon JH, Lee JM, Lee JY, Kim SH, Kim D, Lee HS. Negative hepatitis B envelope antigen predicts intrahepatic recurrence in hepatitis B virus-related hepatocellular carcinoma after ablation therapy. J Gastroenterol Hepatol. 2011 Nov;26(11):1638-45. doi: 10.1111/j.1440-1746.2011.06777.x.

Reference Type DERIVED
PMID: 22011297 (View on PubMed)

Other Identifiers

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10-2006-001

Identifier Type: -

Identifier Source: org_study_id

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