search
Back to results

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

Primary Purpose

Carcinoma, Hepatocellular, Chronic Hepatitis B

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
PEIT
RFTA
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carcinoma, Hepatocellular focused on measuring HBV DNA, HCC, recurrence, PEIT, RFTA

Eligibility Criteria

19 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

percutaneous ethanol injection therapy

radiofrequency thermal ablation

Arm Description

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

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

Outcomes

Primary Outcome Measures

1,3,5 Year-Disease Free Survival (or Recurrence Free Survival)
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
Overall Survival: Number of Participants who Died

Full Information

First Posted
November 7, 2006
Last Updated
March 14, 2019
Sponsor
Seoul National University Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT00397540
Brief Title
The Effect of Viral Load on Intrahepatic Recurrence in Hepatitis B Virus (HBV)-Related Hepatocellular Carcinoma (HCC)
Official Title
Prospective Cohort Study of the Effect of Serum HBV DNA Level on Intrahepatic Recurrence in Locally Treatable, HBV-related HCC Patients
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
October 2004 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
May 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Prospective cohort study Survival Overall survival rate Disease free survival rate Recurrence Cumulative recurrence rate

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Hepatocellular, Chronic Hepatitis B
Keywords
HBV DNA, HCC, recurrence, PEIT, RFTA

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
145 (Actual)

8. Arms, Groups, and Interventions

Arm Title
percutaneous ethanol injection therapy
Arm Type
Active Comparator
Arm Description
Patients with hepatocellular carcinoma who will be treated with PEIT (percutaneous ethanol injection therapy)
Arm Title
radiofrequency thermal ablation
Arm Type
Active Comparator
Arm Description
Patients with hepatocellular carcinoma who will be treated with RFTA (radiofrequency thermal ablation)
Intervention Type
Procedure
Intervention Name(s)
PEIT
Other Intervention Name(s)
PEI, local ablation therapy
Intervention Description
Percutaneous Ethanol Injection Therapy
Intervention Type
Procedure
Intervention Name(s)
RFTA
Other Intervention Name(s)
RFA, local ablation therapy
Intervention Description
Radiofrequency Thermal Ablation
Primary Outcome Measure Information:
Title
1,3,5 Year-Disease Free Survival (or Recurrence Free Survival)
Description
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.
Time Frame
1,3,5 year
Secondary Outcome Measure Information:
Title
Overall Survival
Description
Overall Survival: Number of Participants who Died
Time Frame
through study completion, an average of 3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Won Kim, Professor
Organizational Affiliation
Seoul National University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
23461618
Citation
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.
Results Reference
derived
PubMed Identifier
22011297
Citation
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs