Trial record 28 of 443 for:    hepatitis b | Open Studies

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by Sun Yat-sen University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT00720668
First received: July 21, 2008
Last updated: February 6, 2009
Last verified: February 2009
  Purpose

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 Intervention
Hepatitis B
Hepatocellular Carcinoma
Procedure: radiofrequency ablation

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: The Risk of Exacerbation of Chronic Hepatitis B After Percutaneous Radiofrequency Ablation of Hepatocellular Carcinoma

Resource links provided by NLM:


Further study details as provided by Sun Yat-sen University:

Primary Outcome Measures:
  • The Rate of Exacerbation of chronic hepatitis B after RFA [ Time Frame: one week, one month, one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • survival [ Time Frame: 1, 3, 5-year ] [ Designated as safety issue: No ]
  • mortality [ Time Frame: one month ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: June 2006
Estimated Study Completion Date: May 2010
Estimated Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
patient with hepatocellular carcinoma after radiofrequency ablation
Procedure: radiofrequency ablation
radiofrequency ablation for HCC
Other Name: RFA

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00720668

Contacts
Contact: min-shan chen, MD 86-20-87343117 ext 86-20-87343117 Chminsh@mail.sysu.edu.cn

Locations
China, Guangdong
Cancer Center, Sun Yat-sen University Recruiting
Guangzhou, Guangdong, China, 510060
Contact: Min-Shan Chen, MD    86-20-87343117 ext 86-20-87343117    Chminsh@mail.sysu.edu.cn   
Principal Investigator: Min-Shan Chen, MD         
Sub-Investigator: Yao-Jun Zhang, Doctor         
Sponsors and Collaborators
Sun Yat-sen University
Investigators
Principal Investigator: min-shan chen, MD Department of Hepatobilliary Surgery, Cancer Center, Sun Yat-sen University
  More Information

Publications:
Responsible Party: minshan chen, cancer canter, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT00720668     History of Changes
Other Study ID Numbers: RFA006
Study First Received: July 21, 2008
Last Updated: February 6, 2009
Health Authority: China: Ministry of Health

Keywords provided by Sun Yat-sen University:
hepatitis B
hepatocellular carcinoma
radiofrequency ablation
reactivation

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Hepatitis, Chronic
Hepatitis B, Chronic
Hepatitis, Viral, Human
Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Liver Diseases
Digestive System Diseases
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on April 16, 2014