Prospective Study Comparing Lipiodol Plus Ethanol Solution Compared With Drug-Eluting Beads for Trans-arterial Chemoembolization of Liver in Treatment of Hepatocellular Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Number of Patients with Post-Embolization Syndrome
研究概览
简要总结
Chemoembolization of hepatocellular carcinoma lesions is an accepted and frequently used method for the palliative or curative treatment of these lesions. These attempts are being made to make these patients a better candidate for liver transplant or to provide palliation for their condition.
详细描述
This is a randomized prospective study with two arms, Drug-Eluting Beads with doxorubicin (DEB) and lipiodol ethanol mixture (LEM), with the goal to show non-inferiority of LEM, which if true will facilitate a simple alternative to DEBs. Patients will be randomized to one arm of the study and will remain in that arm if they need to have more embolization in the future. Both of the mentioned methods (DEB and LEM) fall within the standard of care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Child-Pugh class A or B
- •Biopsy proven HCC or hypervascular mass per European Association for the Study of the Liver (EASL) criteria
- •Patient not a candidate for surgical resection or percutaneous ablation
- •age > 18 years old and able to consent
排除标准
- •Child-Pugh class C
- •Model for End-Stage Liver Disease (MELD) score >16
- •Extrahepatic disease
- •Bilateral or main portal vein thrombus
- •Total bilirubin > 2.2
- •Serum albumin < 2.6
- •Life expectancy < 2 months
- •Uncorrected INR > 2
- •Eastern Cooperative Oncology Group (ECOG) status > 2
- •Tumor burden > 50% liver volume
- •Hepatofugal portal venous flow
研究组 & 干预措施
Drug-Eluting Beads with Doxorubicin
Drug-Eluting Beads (DEB) with Doxorubicin is administered via beads that release it to the liver through a groin puncture site and delivered via catheter through the vessels that feed the liver.
干预措施: Drug-Eluting Beads (DEB) with Doxorubicin (Drug)
Lipiodol Ethanol Mixture (LEM)
Lipiodol Ethanol Mixture (LEM) is administered to the liver through a groin puncture site and delivered via catheter through the vessels that feed the liver.
干预措施: Lipiodol Ethanol Mixture (Drug)
结局指标
主要结局
Number of Patients with Post-Embolization Syndrome
时间窗: Week 6 Post Intervention
Count of patients with post-embolizaation syndrome reported which includes fatigue, anorexia, nausea, fever.
次要结局
- Changes in Quality of Life(Baseline and Week 6 After Intervention)
- Patients with Encephalopathy After Embolization(Week 6 Post Intervention)
- Imaging Response(Week 6 Post Intervention)
- Overall Survival(Week 6 After Intervention)
- Comparison of Liver Function Tests Results(Day 0 and Week 6 Post Intervention)
- Number of Patients with Successful Liver Transplant(Week 6 After Intervention)