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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

November 7, 2006
April 18, 2013
October 2006
April 2013   (final data collection date for primary outcome measure)
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.
Not Provided
Complete list of historical versions of study NCT00397540 on ClinicalTrials.gov Archive Site
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
Not Provided
Not Provided
Not Provided
 
The Effect of Viral Load on Intrahepatic Recurrence in Hepatitis B Virus (HBV)-Related Hepatocellular Carcinoma (HCC)
Prospective Cohort Study of the Effect of Serum HBV DNA Level on Intrahepatic Recurrence in Locally Treatable, HBV-related HCC Patients

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.

Prospective cohort study

Survival

  • Overall survival rate
  • Disease free survival rate

Recurrence

  • Cumulative recurrence rate
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Carcinoma, Hepatocellular
  • Hepatitis B Virus
  • Procedure: PEIT
    Percutaneous Ethanol Injection Therapy
    Other Name: PEI, local ablation therapy
  • Procedure: RFTA
    Radiofrequency Thermal Ablation
    Other Name: RFA, local ablation therapy
  • Active Comparator: percutaneous ethanol injection therapy
    Intervention: Procedure: PEIT
  • Active Comparator: radiofrequency thermal ablation
    Intervention: Procedure: RFTA
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
145
April 2013
April 2013   (final data collection date for primary outcome measure)

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
Both
19 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT00397540
10-2006-001
Yes
Won Kim, Seoul National University Hospital
Seoul National University Hospital
Not Provided
Study Director: Won Kim, Professor Seoul National University Hospital
Seoul National University Hospital
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP