UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032072 |
|---|---|
| Receipt number | R000036139 |
| Scientific Title | A randomized controlled trial on radiofrequency ablation using variable and fixed electrodes for the treatment of malignant hepatic tumors |
| Date of disclosure of the study information | 2018/04/03 |
| Last modified on | 2020/02/21 09:58:36 |
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Basic information
Public title
A randomized controlled trial on radiofrequency ablation using variable and fixed electrodes for the treatment of malignant hepatic tumors
Acronym
A randomized controlled trial on radiofrequency ablation using variable and fixed electrodes for the treatment of malignant hepatic tumors
Scientific Title
A randomized controlled trial on radiofrequency ablation using variable and fixed electrodes for the treatment of malignant hepatic tumors
Scientific Title:Acronym
A randomized controlled trial on radiofrequency ablation using variable and fixed electrodes for the treatment of malignant hepatic tumors
Region
| Japan |
Condition
Condition
malignant hepatic tumors
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of the study is to assess the efficacy and safety of radiofrequency ablation using either variable or fixed electrodes to treat malignant hepatic tumors in a randomized controlled trial.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary endpoints are the incidence of adverse events and the short-term treatment response based on contrast-CT using the modified RECIST criteria following one session of radiofrequency ablation.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Adjustable tip electrode RFA system
Interventions/Control_2
fixed tip electrode RFA system
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
(i) ineligible for surgical resection, liver transplantation or patient refusal for surgery
(ii) three or fewer tumors of 3 cm or smaller in diameter, or a single tumor of 5 cm or smaller in diameter
(iii) no extrahepatic metastasis nor vascular invasion
Key exclusion criteria
(i) tumor not visualized by ultrasonography or not accessible percutaneously
(ii) total bilirubin level of 3.0 mg/dl or higher
(iii) platelet count of less than 50x10 9/l or prothrombin activity of less than 50%
(iv) refractory ascites
(v) enterobiliary reflux
Target sample size
210
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | SHUICHIRO SHIINA |
Organization
Juntendo University
Division name
Department of Gastroenterology
Zip code
Address
2-1-1, Hongo, Bunkyo-ku, Tokyo
TEL
03-3813-3111
ivo@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | SHUICHIRO SHIINA |
Organization
Juntendo University
Division name
Department of Gastroenterology
Zip code
Address
2-1-1, Hongo, Bunkyo-ku, Tokyo
TEL
03-3813-3111
Homepage URL
ivo@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
Funding Source
Organization
Juntendo University
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
| 2018 | Year | 04 | Month | 03 | 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
Terminated
Date of protocol fixation
| 2017 | Year | 03 | Month | 23 | Day |
Date of IRB
| 2017 | Year | 05 | Month | 10 | Day |
Anticipated trial start date
| 2017 | Year | 05 | Month | 10 | Day |
Last follow-up date
| 2018 | Year | 10 | Month | 03 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 04 | Month | 03 | Day |
Last modified on
| 2020 | Year | 02 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036139
| Research Plan | |
|---|---|
| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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