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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000034368
Receipt No. R000039180
Scientific Title Ablation therapy for liver and pancreatic cancers using Irreversible electroporation, IRE, NanoKnife
Date of disclosure of the study information 2018/10/06
Last modified on 2019/10/07

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Basic information
Public title Ablation therapy for liver and pancreatic cancers using Irreversible electroporation, IRE, NanoKnife
Acronym IRE therapy for liver and pancreatic cancer
Scientific Title Ablation therapy for liver and pancreatic cancers using Irreversible electroporation, IRE, NanoKnife
Scientific Title:Acronym IRE therapy for liver and pancreatic cancer
Region
Japan

Condition
Condition Liver cancer, Pancreatic cancer
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate efficacy and safety of IRE therapy for liver and pancreatic cancers
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Overall survival period from diagnosis to death.
Key secondary outcomes Adverse events related to IRE therapy

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification YES
Dynamic allocation NO
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Therapy of single time and one day.
Multiple electrode needles (2-6) are inserted in the tumor percutaneously under imaging guidance. Electric currency under high voltage provokes electroporation and apoptosis of cancer cells.
Interventions/Control_2
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

Not applicable
Gender Male and Female
Key inclusion criteria 1. Unresectable liver and pancreatic cancers
2. No distant metastasis
Key exclusion criteria 1. Metallic materials such as metallic stent near the tumor.
2. Arrhythmia and cardiac diseases.
Target sample size 200

Research contact person
Name of lead principal investigator
1st name Fuminori
Middle name
Last name Moriyasu
Organization International University of Health and Welfare Sanno Hospital
Division name Center for Cancer Ablation Therapy
Zip code 107-0052
Address 8-10-16 Akasaka, Minatoku, Tokyo, 107-0052 Japan
TEL 03-3402-3151
Email moriyasu@rb4.so-net.ne.jp

Public contact
Name of contact person
1st name Fuminori
Middle name
Last name Moriyasu
Organization International University of Health and Welfare Sanno Hospital
Division name Center for Cancer Ablation Therapy
Zip code 107-0052
Address 8-10-16 Akasaka, Minatoku, Tokyo, 107-0052 Japan
TEL 03-3402-3151
Homepage URL
Email moriyasu@rb4.so-net.ne.jp

Sponsor
Institute International University of Health and Welfare
Institute
Department

Funding Source
Organization International University of Health and Welfare
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Tokyo Medical University
Name of secondary funder(s)

IRB Contact (For public release)
Organization International University of Health and Welfare
Address 8-10-16 Akasaka, Minatoku, Tokyo, 107-0052 Japan
Tel 03-3402-3301
Email hasegawa1982@iuhw.ac.jp

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 国際医療福祉大学 山王病院(東京都)/International University of health and welfare, Sanno Hospital(Tokyo)
東京医科大学(東京都)/Tokyo Medical University (Tokyo)

Other administrative information
Date of disclosure of the study information
2018 Year 10 Month 06 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications http://www.sannoclc.or.jp/hospital/patient/department/gankyokusho_c/nanoknife6.php
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
2016 Year 04 Month 05 Day
Date of IRB
2016 Year 04 Month 05 Day
Anticipated trial start date
2016 Year 04 Month 18 Day
Last follow-up date
2019 Year 03 Month 31 Day
Date of closure to data entry
2019 Year 06 Month 30 Day
Date trial data considered complete
2019 Year 06 Month 30 Day
Date analysis concluded
2019 Year 09 Month 30 Day

Other
Other related information

Management information
Registered date
2018 Year 10 Month 03 Day
Last modified on
2019 Year 10 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039180

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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