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

NCT ID: NCT00720668

Last Updated: 2009-02-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-06-30

Study Completion Date

2010-05-31

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.

Conditions

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Hepatitis B Hepatocellular Carcinoma

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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1

patient with hepatocellular carcinoma after radiofrequency ablation

radiofrequency ablation

Intervention Type PROCEDURE

radiofrequency ablation for HCC

Interventions

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radiofrequency ablation

radiofrequency ablation for HCC

Intervention Type PROCEDURE

Other Intervention Names

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RFA

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sun Yat-sen University

OTHER

Sponsor Role lead

Responsible Party

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cancer canter, Sun Yat-sen University

Principal Investigators

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min-shan chen, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Hepatobilliary Surgery, Cancer Center, Sun Yat-sen University

Locations

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Cancer Center, Sun Yat-sen University

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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min-shan chen, MD

Role: CONTACT

86-20-87343117 ext. 86-20-87343117

Facility Contacts

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Min-Shan Chen, MD

Role: primary

86-20-87343117 ext. 86-20-87343117

References

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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.

Reference Type RESULT
PMID: 16250051 (View on PubMed)

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.

Reference Type RESULT
PMID: 11923602 (View on PubMed)

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.

Reference Type RESULT
PMID: 16495695 (View on PubMed)

Other Identifiers

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RFA006

Identifier Type: -

Identifier Source: org_study_id

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