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

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ClinicalTrials.gov Identifier: NCT00397540
Recruitment Status : Completed
First Posted : November 9, 2006
Results First Posted : March 15, 2010
Last Update Posted : June 12, 2015
Sponsor:
Information provided by (Responsible Party):
Jung-Hwan Yoon, Seoul National University Hospital

Brief Summary:
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 or disease Intervention/treatment Phase
Carcinoma, Hepatocellular Chronic Hepatitis B Procedure: PEIT Procedure: RFTA Phase 4

Detailed Description:

Prospective cohort study

Survival

  • Overall survival rate
  • Disease free survival rate

Recurrence

  • Cumulative recurrence rate

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 145 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : October 2006
Actual Primary Completion Date : April 2013
Actual Study Completion Date : April 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: percutaneous ethanol injection therapy
Patients with hepatocellular carcinoma who will be treated with PEIT (percutaneous ethanol injection therapy)
Procedure: PEIT
Percutaneous Ethanol Injection Therapy
Other Name: PEI, local ablation therapy

Active Comparator: radiofrequency thermal ablation
Patients with hepatocellular carcinoma who will be treated with RFTA (radiofrequency thermal ablation)
Procedure: RFTA
Radiofrequency Thermal Ablation
Other Name: RFA, local ablation therapy




Primary Outcome Measures :
  1. 1,3,5 Year-Disease Free Survival (or Recurrence Free Survival) [ Time Frame: 1,3,5 year ]
    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 :
  1. 1,3,5-year Overall Survival [ Time Frame: 1,3,5-year ]


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Ages Eligible for Study:   19 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

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 ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jung-Hwan Yoon, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT00397540     History of Changes
Other Study ID Numbers: 10-2006-001
First Posted: November 9, 2006    Key Record Dates
Results First Posted: March 15, 2010
Last Update Posted: June 12, 2015
Last Verified: May 2015

Keywords provided by Jung-Hwan Yoon, Seoul National University Hospital:
HBV DNA
HCC
recurrence
PEIT
RFTA

Additional relevant MeSH terms:
Carcinoma
Hepatitis
Hepatitis, Chronic
Hepatitis B
Recurrence
Hepatitis B, Chronic
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Liver Diseases
Digestive System Diseases
Hepadnaviridae Infections
DNA Virus Infections
Virus Diseases
Hepatitis, Viral, Human
Disease Attributes
Pathologic Processes
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs