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临床试验/NCT01108380
NCT01108380Unknown不适用

Evaluation of Liver Regeneration With Autologous Peripheral Stem Cells Transplantation in the Patient Needed Extensive Hepatectomy

Seoul National University Hospital1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2009年1月最近更新:
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

  1. Patients: 30 patients (10 patients in each 3 group)
  2. 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.
  1. 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.
  1. Allocation: We will allocate patients randomly to three group including control group.
  2. 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

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

申办方类型
Other

研究点 (1)

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