Efficacy of Sequential Arterial and Portal Vein Embolizations on Increasing the Resectability of Hepatitis B Related Primary Hepatocellular Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- the rate of tumor resection after intervention
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age:20-65years old;
- •with a clinical diagnosis of primary liver cancer, with HBsAg positive,without any therapy for tumor;
- •single lesion with a diameter >6.5cm,or multiple lesions locating within half liver or adjacent three lobe;
- •estimated liver remnant volume ≤40%
- •with a liver function of Child-Pugh class A,and ALT≤80IU/l.
排除标准
- •reject to attend；
- •portal vein trunk has been compressed by tumor;
- •diffuse type cancer or with extensive cancer thrombus in main branches of PV,HV,IVC or bile duct;
- •with extrahepatic metastasis;
- •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)
- •with diabetes
- •allergy to iodine
研究组 & 干预措施
TACE+PVE
perform TACE and PVE sequentially
干预措施: PVE (Procedure)
TACE+PVE
perform TACE and PVE sequentially
干预措施: TACE (Procedure)
TACE
perform TACE only
干预措施: TACE (Procedure)
结局指标
主要结局
the rate of tumor resection after intervention
时间窗: 1 to 2 months
次要结局
- rate of survival(1, 3, 5 year)
研究者
ShenFeng
vice president of the Eastern Hepatobiliary Surgery Hospotal
Eastern Hepatobiliary Surgery Hospital