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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Hepatitis B, Hepatocellular Carcinoma

Intervention / Treatment
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* Procedure: radiofrequency ablation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>patient with hepatocellular carcinoma after radiofrequency ablation | Procedure: radiofrequency ablation<br>* radiofrequency ablation for HCC<br>* Other names: RFA;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Rate of Exacerbation of chronic hepatitis B after RFA |  | one week, one month, one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| survival |  | 1, 3, 5-year | 
| mortality |  | one month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hepatitis B, hepatocellular carcinoma, radiofrequency ablation, reactivation