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

Not Applicable

Completed

• Conditions: Hepatocellular Carcinoma
• Interventions: Procedure: TACE; Procedure: PVE

• Registration Number: NCT00834158
• Lead Sponsor: Eastern Hepatobiliary Surgery Hospital

Brief Summary

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.

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.

Study Timeline

• Study Start: 2009-01
• Study First Submitted: 2009-01-31
• Study First Submitted QC: 2009-01-31
• Study First Posted: 2009-02-03
• Primary Completion: 2009-12
• Study Completion: 2010-11
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-30
• Last Update Posted: 2016-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TACE+PVE	PVE	perform TACE and PVE sequentially
TACE	TACE	perform TACE only
TACE+PVE	TACE	perform TACE and PVE sequentially

Primary Outcome Measures

Name	Time	Method
the rate of tumor resection after intervention	1 to 2 months

Secondary Outcome Measures

Name	Time	Method
rate of survival	1, 3, 5 year

Trial Locations

Locations (1)

Eastern Hepatobiliary Surgery Hospital; 🇨🇳 Shanghai, China