NCT01108380Unknown不适用
Evaluation of Liver Regeneration With Autologous Peripheral Stem Cells Transplantation in the Patient Needed Extensive Hepatectomy
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Safety and efficacy, short term outcome
研究概览
简要总结
For patient with liver cirrhosis who need to right or extended right hepatectomy, we will treat with autologous peripheral stem cells transplantation to facilitate liver regeneration. We will asses liver regeneration by evaluation of liver volume and liver function test.
详细描述
- Patients: 30 patients (10 patients in each 3 group)
- Indication:
- Patients with Primary hepatocellular carcinoma combined liver cirrhosis (Hepatitis B, C, Non-B Non-C)
- Planned to right hepatectomy or extended right hepatectomy
- Patients who need right portal vein embolization due to insufficient expected remnant liver volume (< 40%) or severe hepatic dysfunction(ICGR15>10%)
- Child A classification
- ICG R15 < 25%
- Age : 20 - 70 years old
- Expected life period > 3months
- The patients who agreed to this study.
- Contraindication
- Patients who planned liver transplantation
- Age <20 or >70 years old
- Pregnant women
- Patients on acute infection
- Acute hepatic failure
- Child class B or C
- Heart failure
- Existence of bleeding tendency : platelet < 30,000, INR > 2.2, Cr >2.5
- Patients who did not agree to this study.
- Allocation: We will allocate patients randomly to three group including control group.
- Methods
- Group 1: 4 days injection of G-CSF -> Plasma pheresis, Selection of CD34 cell -> Right portal vein embolization and infusion of CD34 cell into left portal vein.
- Group 2: 4 days injection of G-CSF -> Plasma pheresis -> Right portal vein embolization and infusion of mononuclear cell into left portal vein.
- Group 3 (control): Right portal vein embolization
( -> after 4 weeks, operation will be performed) 6. Evaluation: Change of liver volume, liver function test before and after portal vein embolization
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 70 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with Primary hepatocellular carcinoma combined liver cirrhosis (Hepatitis B, C, Non-B Non-C)
- •Planned to right hepatectomy or extended right hepatectomy
- •Patients who need right portal vein embolization due to unsufficient expected remnant liver volume (< 40%) or severe hepatic dysfunction (ICG R15 > 10%)
- •Child A classification
- •ICG R15 < 25%
- •Age: 20 - 70 years old
- •Expected life period > 3months
- •The patients who agreed to this study
排除标准
- •Patients who planned liver transplantation
- •Age < 20 or > 70 years old
- •Pregnant women
- •Patients on acute infection
- •Acute hepatic failure
- •Child class B or C
- •Heart failure
- •Existence of bleeding tendency : platelet < 30,000, INR > 2.2, Cr >2.5
- •Patients who did not agree to this study
结局指标
主要结局
Safety and efficacy, short term outcome
时间窗: 4 weeks after procedure
After portal vein embolization, we will compare liver volume by CT and liver function test by blood test in 3 groups. (Second and forth week)
次要结局
- Safety and efficacy.(12 weeks)
研究者
研究点 (1)
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