UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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
Title of the study (Brief title)	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	KENTO IMAJO
Organization	Yokohama City University Graduate School of Medicine
Division name	Department of Gastroenterology and Hepatology
Address	3-9 Fukuura, Kanazawa-ku, yokohama city
TEL	+81-45-787-2640
Email	kento318@yokohama-cu.ac.jp

Public contact
Name of contact person	KENTO IMAJO
Organization	Yokohama City University Graduate School of Medicine
Division name	Department of Gastroenterology and Hepatology
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)

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

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2018 Year 12 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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