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

Not Applicable

Completed

• Conditions: Chronic Hepatitis B; Carcinoma, Hepatocellular
• Interventions: Procedure: PEIT; Procedure: RFTA

• Registration Number: NCT00397540
• Lead Sponsor: 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.

Detailed Description

Prospective cohort study

Survival

* Overall survival rate

* Disease free survival rate

Recurrence

* Cumulative recurrence rate

Study Timeline

• Study Start: 2004-10
• Study First Submitted: 2006-11-07
• Study First Submitted QC: 2006-11-07
• Study First Posted: 2006-11-09
• Results First Submitted: 2009-09-22
• Results First Submitted QC: 2010-03-02
• Results First Posted: 2010-03-15
• Primary Completion: 2011-05
• Study Completion: 2011-05
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-14
• Last Update Posted: 2019-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 145

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
percutaneous ethanol injection therapy	PEIT	Patients with hepatocellular carcinoma who will be treated with PEIT (percutaneous ethanol injection therapy)
radiofrequency thermal ablation	RFTA	Patients with hepatocellular carcinoma who will be treated with RFTA (radiofrequency thermal ablation)

Primary Outcome Measures

Name	Time	Method
1,3,5 Year-Disease Free Survival (or Recurrence Free Survival)	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

Name	Time	Method
Overall Survival	through study completion, an average of 3 years	Overall Survival: Number of Participants who Died

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of