Clinical trial NCT00834158: Efficacy of Sequential TACE and PVE on the Resectability of Hepatitis B Related HCC
Official title: Efficacy of Sequential Arterial and Portal Vein Embolizations on Increasing the Resectability of Hepatitis B Related Primary Hepatocellular Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hepatocellular Carcinoma
Keywords: Hepatocellular Carcinoma
Hepatitis B
Transarterial chemoembolization (TACE)
Portal vein embolization (PVE)
Surgical resection
Disease-free survival
Overall survival
Lead sponsor: Eastern Hepatobiliary Surgery Hospital
Sponsor class: OTHER
First posted: 2009-02-03
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: the rate of tumor resection after intervention
timeFrame: 1 to 2 months
Secondary outcomes:
measure: rate of survival
timeFrame: 1, 3, 5 year
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Eastern Hepatobiliary Surgery Hospital
Study officials:
affiliation: Eastern Hepatobiliary Surgery Hospital, Second Military Medical University
name: Feng Shen, MD
role: STUDY_CHAIR
References: