Liver reproduction in Radio Frequency Ablation to liver cancer patients and examination of liver function

UMIN ID: UMIN000000932

Registered date:01/12/2010

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: liver cancer
• Date of first enrollment: 2007/10/01
• Target sample size: 30
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

The SNMC group 15 cases From the day of hospitalization for the operation the first and the third day and week 1, 2, 4 and 8. (Blood collection at the 8th week is not obligatory and lack of data of the 8th week does not make condition of discontinuance.) Treatment period, usage and dosage: SNMC is obligatory at 100mL/day during hospitalization. After that at least 180mL/week is to be administered. The treatment period will be 8 weeks in total.
The control group 15 cases: non-SNMC group

Outcome(s)

• Primary Outcome: Biochemical test: AST, ALT, gamma-GTP, TB, DB, PT, and Pre-Alb Liver reproduction promotion marker: HGF, IL-6, and TNF-alpha
• Secondary Outcome: Tumor marker: AFP and PIVKA HCV-RNA test: A quantitative test is done.

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: 1) Basal disease of the cancer of liver is the following: Viral hepatitis other than C type, alcoholic hepatitis, drug induced hepatic injury, autoimmune hepatitis, primary biliary cirrhosis, Hemocromatois and congenital metabolic liver diseases such as Wilson disease. 2) Patients of untreated esophageal piles of F2 or patients of esophageal piles with positive RC sign. 3) Pregnant women and those with possibility of pregnancy. 4) Children and women lactating. 5) Stronger Neo-Minophagen C contra- indicated patients. 6) Other patients judged by the responsible investigators adequate to exclude.

Related Information

• Primary Sponsor: HYOGO COLLEGE OF MEDICINE Internal medicine
• Source(s) of Monetary Support: None