UMIN-CTR Clinical Trial

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

Patients with liver cancer that the local therapy is possible

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Malignancy

Genomic information

NO

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

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

Study type

Interventional

Basic design

Parallel

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

No treatment

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Yokohama City University Graduate School of Medicine

Institute

Department

Personal name

Organization

Yokohama City University Graduate School of Medicine

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2019

Year

01

Month

07

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related 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