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Sponsored by: |
Eastern Hepatobiliary Surgery Hospital |
---|---|
Information provided by: | Eastern Hepatobiliary Surgery Hospital |
ClinicalTrials.gov Identifier: | NCT00834158 |
A primary hepatocellular carcinoma (HCC) is generally regarded as unresectable if the future liver remnant (FLR)≤40% of total liver volume in patient with underlying liver disease, such as hepatitis B. In China, TACE is the most common treatment for these unresectable HCC. Recently, PVE has been employed to enlarge the FLR of the patients so as to increase the resectability and surgical safety of major hepatectomies. In order to shut the arterio-portal shunt in the liver and control the tumor progress TACE sometimes is performed before PVE. In this study we design a randomized control trial to investigate the efficacy of sequential TACE and PVE on increasing the resectability of hepatitis B related HCC compared with TACE alone.
Condition | Intervention |
---|---|
Hepatocellular Carcinoma |
Procedure: TACE Procedure: PVE |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Efficacy of Sequential Arterial and Portal Vein Embolizations on Increasing the Resectability of Hepatitis B Related Primary Hepatocellular Carcinoma |
Estimated Enrollment: | 20 |
Study Start Date: | January 2009 |
Estimated Study Completion Date: | November 2010 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
TACE: Active Comparator
perform TACE only
|
Procedure: TACE
1 time
|
TACE+PVE: Experimental
perform TACE and PVE sequentially
|
Procedure: TACE
1 time
Procedure: PVE
1 time
|
In China, primary hepatocellular carcinoma (HCC) is mostly a hepatitis B related disease. The liver function of these patients has been damaged, which often limit the execution of major hepatectomy. A tumor is generally regarded as unresectable if the future liver remnant (FLR)≤40% of total liver volume in patient with underlying liver disease. In China, TACE is the most common treatment for these unresectable HCC. TACE can slow down tumor progress but has little effect on enlarging FLR. Recently, PVE has been employed to enlarge the FLR of the patients so as to increase the resectability and surgical safety of major hepatectomies. But the intrahepatic arterioportal shunt and the tumor progress has decreased the effect of PVE. In order to shut the arterioportal shunt and control the tumor progress TACE sometimes is performed before PVE. In this study we design a randomized control trial to investigate the efficacy of sequential TACE and PVE on increasing the resectability of hepatitis B related HCC compared with TACE alone.
Ages Eligible for Study: | 20 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion criteria:
Contact: Yi Wang, MD | +86 21 81870791 | wangyi-ehbh@163.com |
China | |
Eastern Hepatobiliary Surgery Hospital | Recruiting |
Shanghai, China, 200438 | |
Contact: Yi Wang, MD +86 21 81870791 wangyi-ehbh@163.com | |
Principal Investigator: Yi Wang, MD |
Study Chair: | Feng Shen, MD | Eastern Hepatobiliary Surgery Hospital, Second Military Medical University |
Responsible Party: | Department of Hepatic SurgeryⅡ, Eastern Hepatobiliary Surgery Hospital ( Yi Wang ) |
Study ID Numbers: | EHBH-RCT-2008-006 |
Study First Received: | January 31, 2009 |
Last Updated: | February 22, 2009 |
ClinicalTrials.gov Identifier: | NCT00834158 History of Changes |
Health Authority: | China: Ministry of Health |
Hepatocellular Carcinoma Hepatitis B Transarterial chemoembolization (TACE) Portal vein embolization (PVE) |
Surgical resection Disease-free survival Overall survival |
Liver Diseases Digestive System Neoplasms Carcinoma, Hepatocellular Hepatitis, Viral, Human Carcinoma Hepatitis Virus Diseases Liver Neoplasms |
Digestive System Diseases Hepatitis B Gastrointestinal Neoplasms DNA Virus Infections Hepatocellular Carcinoma Adenocarcinoma Neoplasms, Glandular and Epithelial |
Liver Diseases Digestive System Neoplasms Neoplasms by Histologic Type Carcinoma, Hepatocellular Hepatitis, Viral, Human Hepadnaviridae Infections Carcinoma Liver Neoplasms Hepatitis |
Virus Diseases Neoplasms Neoplasms by Site Digestive System Diseases Hepatitis B DNA Virus Infections Adenocarcinoma Neoplasms, Glandular and Epithelial |