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

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

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2010-11-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Hepatocellular Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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TACE

perform TACE only

Group Type ACTIVE_COMPARATOR

TACE

Intervention Type PROCEDURE

1 time

TACE+PVE

perform TACE and PVE sequentially

Group Type EXPERIMENTAL

TACE

Intervention Type PROCEDURE

1 time

PVE

Intervention Type PROCEDURE

1 time

Interventions

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TACE

1 time

Intervention Type PROCEDURE

PVE

1 time

Intervention Type PROCEDURE

Other Intervention Names

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transaterial chemoemblization portal vein embolization

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No