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

This study has been completed.
Sponsor:
Information provided by:
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT00397540
First received: November 7, 2006
Last updated: April 18, 2013
Last verified: April 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Carcinoma, Hepatocellular
Hepatitis B Virus
 Procedure: PEIT
Procedure: RFTA
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prospective Cohort Study of the Effect of Serum HBV DNA Level on Intrahepatic Recurrence in Locally Treatable, HBV-related HCC Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • Disease Free Survival (or Recurrence Free Survival) [ Time Frame: 1,3,5-year ] [ Designated as safety issue: No ]
    The disease free survival is defined as the total number of surviving participants without intrahepatic recurrence of hepatocellular carcinoma for 1, 3, and 5 years.


Secondary Outcome Measures:
  • Overall Survival [ Time Frame: 1,3,5-year ] [ Designated as safety issue: No ]
    The overall survival is defined as the total number of the surviving participants irrespective of intrahepatic recurrence of hepatocellular carcinoma for 1, 3, and 5 years


Enrollment: 145
Study Start Date: October 2006
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: percutaneous ethanol injection therapy Procedure: PEIT
Percutaneous Ethanol Injection Therapy
Other Name: PEI, local ablation therapy
Active Comparator: radiofrequency thermal ablation Procedure: RFTA
Radiofrequency Thermal Ablation
Other Name: RFA, local ablation therapy

Detailed Description:

Prospective cohort study

Survival

  • Overall survival rate
  • Disease free survival rate

Recurrence

  • Cumulative recurrence rate
  Eligibility

Ages Eligible for Study:   19 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00397540

Locations
Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Sponsors and Collaborators
Seoul National University Hospital
Investigators
Study Director: Won Kim, Professor Seoul National University Hospital
  More Information

No publications provided by Seoul National University Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Won Kim, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT00397540     History of Changes
Other Study ID Numbers: 10-2006-001
Study First Received: November 7, 2006
Results First Received: September 22, 2009
Last Updated: April 18, 2013
Health Authority: Korea: Food and Drug Administration

Keywords provided by Seoul National University Hospital:
HBV DNA
HCC
recurrence
PEIT
RFTA

Additional relevant MeSH terms:
Carcinoma
Hepatitis
Hepatitis A
Hepatitis B
Recurrence
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
 Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Disease Attributes
Pathologic Processes
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on May 23, 2013