UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035411 |
|---|---|
| Receipt number | 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 10:41:30 |
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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
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
kento318@yokohama-cu.ac.jp
Public contact
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
kento318@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040347
