UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013331 |
|---|---|
| Receipt number | R000015557 |
| Scientific Title | A study of RFA which performed to the Hepatocellular carcinoma with affixing return electrode to a back |
| Date of disclosure of the study information | 2014/04/01 |
| Last modified on | 2016/03/04 13:48:29 |
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Basic information
Public title
A study of RFA which performed to the Hepatocellular carcinoma with affixing return electrode to a back
Acronym
RFA with affixing return electrode to a back
Scientific Title
A study of RFA which performed to the Hepatocellular carcinoma with affixing return electrode to a back
Scientific Title:Acronym
RFA with affixing return electrode to a back
Region
| Japan |
Condition
Condition
Hepatocellilar carcinoma
Classification by specialty
| Medicine in general | Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy and safety of radiofrequency ablation which perfomed with affixing return electrode to a back.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Ablation time to complete RFA
Arrival temperature
Complications
Selection of Cool-tip needles
VAS scale
Key secondary outcomes
WBC, RBC, Hb, Ht, Plt, TP, Alb, AST, ALT, ALP, gamma-GTP, Cr, CRP and BS one day after RFA
maximal ablation diameter x minimal ablation diameter by CT one day after RFA
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
group A: with affixing return electrode to both thighs
Interventions/Control_2
group B: with affixing return electrode to a back
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
1)the case who was diagnosed hepatocellular carcinoma by biopsy or clinical diagnosis
2)the case adapted the following item
WBC > 1000/mm3
Plt > 50000/mm3
Hb > 8.5g/dL
T.Bil < 3.0mg/dL
Cr < 1.5mg/dL
AST < 380IU/L
ALT < 350IU/L
PT(%) > 40%
Key exclusion criteria
1) The case who cannot reply by any modality
2) The case who have severe complication without chronic hepatitis and liver cirrhosis
3) The case who have severe hypersensitivity
4) The case who is or may be pregnant and is nursing
5) The case who was judged with inadequacy by the doctor
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuya Kariyama |
Organization
Okayama City Hospital
Division name
Department of liver disease center
Zip code
Address
Amase6-10, kita-ku, Okayama, Okayama, Japan
TEL
086-225-3171
kariyama777@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuya Kariyama |
Organization
Okayama City Hospital
Division name
Department of liver disease center
Zip code
Address
Amase6-10, kita-ku, Okayama, Okayama, Japan
TEL
086-225-3171
Homepage URL
kariyama777@gmail.com
Sponsor or person
Institute
Okayama City Hospital
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
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
| 2014 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
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
| 2013 | Year | 06 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2015 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2015 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2016 | Year | 01 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 03 | Month | 04 | Day |
Last modified on
| 2016 | Year | 03 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015557
