The Risk of Exacerbation of Chronic Hepatitis B After Percutaneous Radiofrequency Ablation of Hepatocellular Carcinoma

• Conditions: Hepatitis B; Hepatocellular Carcinoma
• Interventions: Procedure: radiofrequency ablation

• Registration Number: NCT00720668
• Lead Sponsor: Sun Yat-sen University

Brief Summary

This study aim to find out the risk of exacerbation of chronic hepatitis B after percutaneous radiofrequency ablation (RFA) or hepatectomy for HCC, and it's effect to treatment outcome.

Detailed Description

It has been reported that HBV replication can be reacted after chemotherapy or immunotherapy, which will lead to exacerbation of chronic hepatitis B (ECHB). It is still unknown that if percutaneous radiofrequency ablation or liver resection for hepatocellular carcinoma (HCC) will react the replication of HBV or not. This study aim to find out the risk of exacerbation of chronic hepatitis B after percutaneous radiofrequency ablation (RFA) or hepatectomy for HCC, and it's effect to treatment outcome.

Study Timeline

• Study Start: 2006-06
• Study First Submitted: 2008-07-21
• Study First Submitted QC: 2008-07-21
• Study First Posted: 2008-07-23
• Status Verified: 2009-02
• Last Update Submitted: 2009-02-06
• Last Update Posted: 2009-02-09
• Primary Completion: 2009-03
• Study Completion: 2010-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Age 18 - 75 years
• HBV carrier with HCC
• After percutaneous radiofrequency ablation;
• No history of encephalopathy, ascites refractory to diuretics or variceal bleeding
• No HCV or HIV co-infection
• No previous treatment of HCC
• No previous treatment of HBV except Lamivudine

Exclusion Criteria

• Patient compliance is poor
• Active clinically serious infections ( > grade 2 National Cancer Institute [NCI]-Common Terminology Criteria for Adverse Events [CTCAE] version 3.0)
• Known history of human immunodeficiency virus (HIV) infection
• Known Central Nervous System tumors including metastatic brain disease
• Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry
• Distantly extrahepatic metastasis
• History of organ allograft
• Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results
• Excluded therapies and medications, previous and concomitant
• Prior use of any systemic anti-cancer treatment for HCC, eg. chemotherapy, immunotherapy or hormonal therapy (except that hormonal therapy for supportive care is permitted). Antiviral treatment is allowed, however interferon therapy must be stopped at least 4 weeks prior randomization
• Prior use of systemic investigational agents for HCC
• Autologous bone marrow transplant or stem cell rescue within four months of start of study drug

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1	radiofrequency ablation	patient with hepatocellular carcinoma after radiofrequency ablation

Primary Outcome Measures

Name	Time	Method
The Rate of Exacerbation of chronic hepatitis B after RFA	one week, one month, one year

Secondary Outcome Measures

Name	Time	Method
survival	1, 3, 5-year
mortality	one month

Trial Locations

Locations (1)

Cancer Center, Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China