UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009244 |
|---|---|
| Receipt number | R000009394 |
| Scientific Title | Assessment of recurrence rate of radiofrequency ablation in the corona enhancement area. |
| Date of disclosure of the study information | 2012/11/01 |
| Last modified on | 2019/05/14 09:39:20 |
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Basic information
Public title
Assessment of recurrence rate of radiofrequency ablation in the corona enhancement area.
Acronym
Assessment of recurrence rate of radiofrequency ablation
Scientific Title
Assessment of recurrence rate of radiofrequency ablation in the corona enhancement area.
Scientific Title:Acronym
Assessment of recurrence rate of radiofrequency ablation
Region
| Japan |
Condition
Condition
hepatocellular carcinoma
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the area of recurrence lesion after radio frequency ablation
Basic objectives2
Others
Basic objectives -Others
recurrence rate
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
recurrence rate
Key secondary outcomes
side effect
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 20 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
tumor diameter is more than 30 mm
tumor number is more than 3
number of platelet is more than 30000
PT is more than 50 %
Key exclusion criteria
extrahepatic metastasis
invasion of intrahepatic vessel
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoichi Hiasa |
Organization
Ehime University
Division name
Gastroenterology and Metabology
Zip code
Address
Shizukawa 454, Ehimeken, Touon-shi, Japan
TEL
089-960-5308
hiasa@m.ehime-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masashi Hirooka |
Organization
Ehime University
Division name
Gastroenterology and Metabology
Zip code
Address
Shizukawa 454, Ehimeken, Touon-shi, Japan
TEL
+81-89-960-5308
Homepage URL
masashih@m.ehime-u.ac.jp
Sponsor or person
Institute
Ehime University
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
| 2012 | Year | 11 | 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
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
| 2012 | Year | 04 | Month | 23 | Day |
Date of IRB
| 2012 | Year | 04 | Month | 23 | Day |
Anticipated trial start date
| 2012 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 05 | Month | 14 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2012 | Year | 11 | Month | 01 | Day |
Last modified on
| 2019 | Year | 05 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009394
| Research Plan | |
|---|---|
| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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