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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by Eastern Hepatobiliary Surgery Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Eastern Hepatobiliary Surgery Hospital
ClinicalTrials.gov Identifier:
NCT00834158
First received: January 31, 2009
Last updated: February 22, 2009
Last verified: February 2009
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 Eastern Hepatobiliary Surgery Hospital:

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

Secondary Outcome Measures:
  • rate of survival [ Time Frame: 1, 3, 5 year ] [ Designated as safety issue: Yes ]

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
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

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00834158

Contacts
Contact: Yi Wang, MD +86 21 81870791 wangyi-ehbh@163.com

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

No publications provided

Responsible Party: Yi Wang, Department of Hepatic SurgeryⅡ, Eastern Hepatobiliary Surgery Hospital
ClinicalTrials.gov Identifier: NCT00834158     History of Changes
Other Study ID Numbers: EHBH-RCT-2008-006
Study First Received: January 31, 2009
Last Updated: February 22, 2009
Health Authority: China: Ministry of Health

Keywords provided by 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
Carcinoma, Hepatocellular
Hepatitis
Hepatitis B
Adenocarcinoma
Digestive System Diseases
Digestive System Neoplasms
DNA Virus Infections
Hepadnaviridae Infections
Hepatitis, Viral, Human
Liver Diseases
Liver Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Virus Diseases

ClinicalTrials.gov processed this record on October 23, 2014