UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000932 |
|---|---|
| Receipt number | R000001117 |
| Scientific Title | Liver reproduction in Radio Frequency Ablation to liver cancer patients and examination of liver function |
| Date of disclosure of the study information | 2010/12/01 |
| Last modified on | 2011/04/19 12:12:10 |
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Basic information
Public title
Liver reproduction in Radio Frequency Ablation to liver cancer patients and examination of liver function
Acronym
Liver reproduction in Radio Frequency Ablation to liver cancer patients and examination of liver function
Scientific Title
Liver reproduction in Radio Frequency Ablation to liver cancer patients and examination of liver function
Scientific Title:Acronym
Liver reproduction in Radio Frequency Ablation to liver cancer patients and examination of liver function
Region
| Japan |
Condition
Condition
liver cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To make comparative study with the control group using Stronger Neo-Minophagen C (SNMC) about liver reproduction and improvement of liver function in the Radio Frequency Ablation (RFA) with liver cancer patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Biochemical test: AST, ALT, gamma-GTP, TB, DB, PT, and Pre-Alb
Liver reproduction promotion marker: HGF, IL-6, and TNF-alpha
Key secondary outcomes
Tumor marker: AFP and PIVKA
HCV-RNA test: A quantitative test is
done.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
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.
Interventions/Control_2
The control group 15 cases: non-SNMC group
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients of primary liver cancer due to chronic hepatitis C with Child Pugh grade A and B.
Key exclusion 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.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shuhei NISHIGUCHI |
Organization
HYOGO COLLEGE OF MEDICINE
Division name
Internal medicine
Zip code
Address
1-1 Mukogawa, Nishinomiya, Hyogo, 663-8501 JAPAN
TEL
0798-45-6471
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shuhei NISHIGUCHI |
Organization
HYOGO COLLEGE OF MEDICINE
Division name
Internal medicine
Zip code
Address
1-1 Mukogawa, Nishinomiya, Hyogo, 663-8501 JAPAN
TEL
Homepage URL
nishiguc@hyo-med.ac.jp
Sponsor or person
Institute
HYOGO COLLEGE OF MEDICINE Internal medicine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 12 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Conclusion
The treatment group and non-treatment group was five patients each, total10patients. The treatment group was hospitalized (one week) and received100mL daily injection of SNMC.
Significant difference was observed with ALT and gamma-GTP in the treatment group.
HGF value was higher in the non-treatment group. However, the two groups had different baseline and no significant difference was observed with the rate of decrease. The result, therefore, makes us to conclude that no influence was seen with the HGF value.
Area of RFA ablation was so small as about 3cm GL seemed to have had no effect on the amount of HGF secretion.
SNMC100mL was administered every day after RFA, and no remarkable side effects were observed. As there were no events that prevent treatment by RFA, the results suggested a safe use of 100mL SNMC after the treatment by RFA.
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2007 | Year | 08 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
| 2011 | Year | 04 | Month | 01 | Day |
Date trial data considered complete
| 2011 | Year | 04 | Month | 01 | Day |
Date analysis concluded
| 2011 | Year | 04 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2007 | Year | 12 | Month | 05 | Day |
Last modified on
| 2011 | Year | 04 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001117
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
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