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Trial record 1 of 1 for:    NCT00720668
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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

July 21, 2008
February 6, 2009
June 2006
March 2009   (final data collection date for primary outcome measure)
The Rate of Exacerbation of chronic hepatitis B after RFA [ Time Frame: one week, one month, one year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00720668 on ClinicalTrials.gov Archive Site
  • survival [ Time Frame: 1, 3, 5-year ] [ Designated as safety issue: No ]
  • mortality [ Time Frame: one month ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
The Risk of Exacerbation of Chronic Hepatitis B After Percutaneous Radiofrequency Ablation of Hepatocellular Carcinoma
The Risk of Exacerbation of Chronic Hepatitis B After Percutaneous Radiofrequency Ablation of Hepatocellular Carcinoma

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.

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.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

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

  • Hepatitis B
  • Hepatocellular Carcinoma
Procedure: radiofrequency ablation
radiofrequency ablation for HCC
Other Name: RFA
1
patient with hepatocellular carcinoma after radiofrequency ablation
Intervention: Procedure: radiofrequency ablation

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
May 2010
March 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact: min-shan chen, MD 86-20-87343117 ext 86-20-87343117 Chminsh@mail.sysu.edu.cn
China
 
NCT00720668
RFA006
Yes
minshan chen, cancer canter, Sun Yat-sen University
Sun Yat-sen University
Not Provided
Principal Investigator: min-shan chen, MD Department of Hepatobilliary Surgery, Cancer Center, Sun Yat-sen University
Sun Yat-sen University
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP