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

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 Overview

• Status: Unknown
• Conditions: Hepatitis B; Hepatocellular Carcinoma
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

• Study Contact: Name: min-shan chen, MD; Phone Number: 86-20-87343117 86-20-87343117; Email: Chminsh@mail.sysu.edu.cn

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510060
      • Recruiting
      • Cancer Center, Sun Yat-sen University
      • Contact: min-shan chen, MD; Phone Number: 86-20-87343117 86-20-87343117; Email: Chminsh@mail.sysu.edu.cn
      • Principal Investigator: min-shan chen, MD
      • Sub-Investigator: yao-jun zhang, Doctor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

patients with hepatocellular carcinoma (HCC) after percutaneous radiofrequency ablation.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Sun Yat-sen University
• Investigators: Principal Investigator: min-shan chen, MD, Department of Hepatobilliary Surgery, Cancer Center, Sun Yat-sen University

Publications and helpful links

General Publications

• Bruix J, Sherman M; Practice Guidelines Committee, American Association for the Study of Liver Diseases. Management of hepatocellular carcinoma. Hepatology. 2005 Nov;42(5):1208-36. doi: 10.1002/hep.20933. No abstract available.
• Poon RT, Fan ST, Tsang FH, Wong J. Locoregional therapies for hepatocellular carcinoma: a critical review from the surgeon's perspective. Ann Surg. 2002 Apr;235(4):466-86. doi: 10.1097/00000658-200204000-00004.
• Chen MS, Li JQ, Zheng Y, Guo RP, Liang HH, Zhang YQ, Lin XJ, Lau WY. A prospective randomized trial comparing percutaneous local ablative therapy and partial hepatectomy for small hepatocellular carcinoma. Ann Surg. 2006 Mar;243(3):321-8. doi: 10.1097/01.sla.0000201480.65519.b8.

Study record dates

Study Major Dates

• Study Start: June 1, 2006
• Primary Completion (Anticipated): March 1, 2009
• Study Completion (Anticipated): May 1, 2010

Study Registration Dates

• First Submitted: July 21, 2008
• First Submitted That Met QC Criteria: July 21, 2008
• First Posted (Estimate): July 23, 2008

Study Record Updates

• Last Update Posted (Estimate): February 9, 2009
• Last Update Submitted That Met QC Criteria: February 6, 2009
• Last Verified: February 1, 2009

More Information

Terms related to this study

• Keywords: radiofrequency ablation; hepatocellular carcinoma; hepatitis B; reactivation
• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Digestive System Neoplasms; Liver Diseases; Hepatitis, Viral, Human; Hepadnaviridae Infections; DNA Virus Infections; Liver Neoplasms; Enterovirus Infections; Picornaviridae Infections; Hepatitis, Chronic; Carcinoma; Hepatitis B; Hepatitis; Carcinoma, Hepatocellular; Hepatitis A; Hepatitis B, Chronic
• Other Study ID Numbers: RFA006