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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000035411
Receipt No. R000040347
Scientific Title Assessment of the temperature of the central and peripheral ablation area induced by a new microwave ablation system and radiofrequency ablation system for the liver cancer
Date of disclosure of the study information 2019/01/07
Last modified on 2018/12/30

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Basic information
Public title Assessment of the temperature of the central and peripheral ablation area induced by a new microwave ablation system and radiofrequency ablation system for the liver cancer
Acronym Assessment of the temperature the central and peripheral ablation area induced by local therapy for the liver cancer
Scientific Title Assessment of the temperature of the central and peripheral ablation area induced by a new microwave ablation system and radiofrequency ablation system for the liver cancer
Scientific Title:Acronym Assessment of the temperature the central and peripheral ablation area induced by local therapy for the liver cancer
Region
Japan

Condition
Condition Patients with liver cancer that the local therapy is possible
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 A new system for microwave ablation can generate a large and spherical ablation zone. However, due to its characteristics, there is a possibility that heat is transferred to the surrounding non-target organ. In this study, the temperature of the central and peripheral ablation area obtained by the microwave system and the conventional radiofrequency wave ablation therapy are measured, and the spread of heat to peripheral organs is examined.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The temperature of the central and peripheral ablation area induced by a new microwave ablation system and radiofrequency ablation system for the liver cancer
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Diagnosis
Type of intervention
Maneuver
Interventions/Control_1 The temperature measurement using by a temperature sensor for microwave ablation
Interventions/Control_2 The temperature measurement using by a temperature sensor for radiofrequecy ablation
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 Inclusion criteria for patients with HCC were as follows: the presence of a potentially curable liver-confined disease and disease unsuitable to hepatic resection alone because of inadequate functional liver reserve. All the patients with HCC presented with different degrees of cirrhosis, with Child-Pugh class A or B. Inclusion criteria for patients with liver metastases were: curative intent of liver-confined disease, and contraindication to surgery and local liver disease control when other treatments such as radiotherapy or chemotherapy were applied to extrahepatic tumor sites.
Key exclusion criteria The exclusion criteria for patients were: age < 19 years; known or suspected pregnancy; abnormal results of a serological coagulation screen; or tumor not accessible percutaneously.
Target sample size 20

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name KENTO IMAJO
Organization Yokohama City University Graduate School of Medicine
Division name Department of Gastroenterology and Hepatology
Zip code
Address 3-9 Fukuura, Kanazawa-ku, yokohama city
TEL +81-45-787-2640
Email kento318@yokohama-cu.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name KENTO IMAJO
Organization Yokohama City University Graduate School of Medicine
Division name Department of Gastroenterology and Hepatology
Zip code
Address 3-9 Fukuura, Kanazawa-ku, yokohama city
TEL +81-45-787-2640
Homepage URL
Email kento318@yokohama-cu.ac.jp

Sponsor
Institute Yokohama City University Graduate School of Medicine
Institute
Department

Funding Source
Organization Yokohama City University Graduate School of Medicine
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
2019 Year 01 Month 07 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 Open public recruiting
Date of protocol fixation
2018 Year 12 Month 01 Day
Date of IRB
Anticipated trial start date
2018 Year 12 Month 17 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 12 Month 30 Day
Last modified on
2018 Year 12 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040347

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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