HBV-HCC: The Risk of Exacerbation of Chronic Hepatitis B After Percutaneous Radiofrequency Ablation of Hepatocellular Carcinoma

Sponsor

Sun Yat-sen University (Other)

Overall Status

Unknown status

CT.gov ID

NCT00720668

Collaborator

(none)

200

Enrollment

Location

Duration (Months)

4.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hepatitis B Hepatocellular Carcinoma	Procedure: radiofrequency ablation

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 Design

Study Type:

Observational

Anticipated Enrollment :

200 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Jun 1, 2006

Anticipated Primary Completion Date :

Mar 1, 2009

Anticipated Study Completion Date :

May 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
1 patient with hepatocellular carcinoma after radiofrequency ablation	Procedure: radiofrequency ablation radiofrequency ablation for HCC Other Names: RFA

Arm

Intervention/Treatment

patient with hepatocellular carcinoma after radiofrequency ablation

Procedure: radiofrequency ablation

radiofrequency ablation for HCC

Other Names:

RFA

Outcome Measures

Primary Outcome Measures

The Rate of Exacerbation of chronic hepatitis B after RFA [one week, one month, one year]

Secondary Outcome Measures

survival [1, 3, 5-year]
mortality [one month]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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