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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000032072
Receipt No. 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 2018/04/03

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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
Email 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
Email ivo@juntendo.ac.jp

Sponsor
Institute Juntendo University
Institute
Department

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
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
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 Preinitiation
Date of protocol fixation
2017 Year 03 Month 23 Day
Date of IRB
Anticipated trial start date
2017 Year 05 Month 10 Day
Last follow-up date
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
2018 Year 04 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036139

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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