Prospective Cohort Study of the Effect of Serum HBV DNA Level on Intrahepatic Recurrence in Locally Treatable, HBV-related HCC Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 145
- Locations
- 1
- Primary Endpoint
- 1,3,5 Year-Disease Free Survival (or Recurrence Free Survival)
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 19 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
radiofrequency thermal ablation
Patients with hepatocellular carcinoma who will be treated with RFTA (radiofrequency thermal ablation)
Intervention: RFTA (Procedure)
percutaneous ethanol injection therapy
Patients with hepatocellular carcinoma who will be treated with PEIT (percutaneous ethanol injection therapy)
Intervention: PEIT (Procedure)
Outcomes
Primary Outcomes
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 Outcomes
- Overall Survival(through study completion, an average of 3 years)
Investigators
Jung-Hwan Yoon
Professor
Seoul National University Hospital