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Efficacy of Sequential TACE and PVE on the Resectability of Hepatitis B Related HCC (TACEPVE)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00834158
First Posted: February 3, 2009
Last Update Posted: April 1, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
ShenFeng, Eastern Hepatobiliary Surgery Hospital
  Purpose
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: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of Sequential Arterial and Portal Vein Embolizations on Increasing the Resectability of Hepatitis B Related Primary Hepatocellular Carcinoma

Resource links provided by NLM:


Further study details as provided by ShenFeng, Eastern Hepatobiliary Surgery Hospital:

Primary Outcome Measures:
  • the rate of tumor resection after intervention [ Time Frame: 1 to 2 months ]

Secondary Outcome Measures:
  • rate of survival [ Time Frame: 1, 3, 5 year ]

Enrollment: 20
Study Start Date: January 2009
Study Completion Date: November 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: TACE
perform TACE only
Procedure: TACE
1 time
Other Name: transaterial chemoemblization
Experimental: TACE+PVE
perform TACE and PVE sequentially
Procedure: TACE
1 time
Other Name: transaterial chemoemblization
Procedure: PVE
1 time
Other Name: portal vein embolization

Detailed Description:
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. age:20-65years old;
  2. with a clinical diagnosis of primary liver cancer, with HBsAg positive,without any therapy for tumor;
  3. single lesion with a diameter >6.5cm,or multiple lesions locating within half liver or adjacent three lobe;
  4. estimated liver remnant volume ≤40%
  5. with a liver function of Child-Pugh class A,and ALT≤80IU/l.

Exclusion criteria:

  1. reject to attend;
  2. portal vein trunk has been compressed by tumor;
  3. diffuse type cancer or with extensive cancer thrombus in main branches of PV,HV,IVC or bile duct;
  4. with extrahepatic metastasis;
  5. with obvious portal hypertension (with moderate to severe varix in esophagus and/or gastric fundus, enlarged spleen,WBC<4×109/L, PLT<80×109/L)
  6. with diabetes
  7. allergy to iodine
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00834158


Locations
China
Eastern Hepatobiliary Surgery Hospital
Shanghai, China, 200438
Sponsors and Collaborators
Eastern Hepatobiliary Surgery Hospital
Investigators
Study Chair: Feng Shen, MD Eastern Hepatobiliary Surgery Hospital, Second Military Medical University
  More Information

Responsible Party: ShenFeng, vice president of the Eastern Hepatobiliary Surgery Hospotal, Eastern Hepatobiliary Surgery Hospital
ClinicalTrials.gov Identifier: NCT00834158     History of Changes
Other Study ID Numbers: EHBH-RCT-2008-006
First Submitted: January 31, 2009
First Posted: February 3, 2009
Last Update Posted: April 1, 2016
Last Verified: March 2016

Keywords provided by ShenFeng, Eastern Hepatobiliary Surgery Hospital:
Hepatocellular Carcinoma
Hepatitis B
Transarterial chemoembolization (TACE)
Portal vein embolization (PVE)
Surgical resection
Disease-free survival
Overall survival

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