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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000000932
Receipt No. 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

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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
Email

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
Email nishiguc@hyo-med.ac.jp

Sponsor
Institute HYOGO COLLEGE OF MEDICINE Internal medicine
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001117

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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