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.
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. 3. 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. 4. Allocation: We will allocate patients randomly to three group including control group. 5. 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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Plasma pheresis : With insertin of 2 intravenous line, plasmapheresis will be done with COBE BCT Inc. It will be performed under supervision of clinical laboratorians and doctors. Right portal vein : Under ultrasonography guided, left portal vein be punctured. Right portal vein will be embolized by coil or gelfoam.
Ho-Seong Han
Seongnam-si, Gyeonggi-do, South Korea
RECRUITINGSafety and efficacy, short term outcome
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)
Time frame: 4 weeks after procedure
Safety and efficacy.
After 4 weeks of portal vein embolization, hepatectomy woul be performed in indicated patients. After hepatectomy, until 12 weeks, we will compare remnant liver volume by CT and liver function test by blood test.
Time frame: 12 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.