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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000013732
Receipt No. R000016033
Scientific Title The assesssment of efficacy and safety of Irreversible Electroporation (IRE) for patients with hepatocellular carcinoma (HCC)
Date of disclosure of the study information 2014/04/16
Last modified on 2014/07/03

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Basic information
Public title The assesssment of efficacy and safety of Irreversible Electroporation (IRE) for patients with hepatocellular carcinoma (HCC)
Acronym IRE therapy for patients with HCC
Scientific Title The assesssment of efficacy and safety of Irreversible Electroporation (IRE) for patients with hepatocellular carcinoma (HCC)
Scientific Title:Acronym IRE therapy for patients with HCC
Region
Japan

Condition
Condition Hepatocellualr carcinoma
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To assesse the efficacy and safety of Irreversible Electroporation (IRE) for patients with HCC.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase I

Assessment
Primary outcomes the effect and usefulness of therapy
Key secondary outcomes the safety

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Irreversible Electroporation(IRE)
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
80 years-old >
Gender Male and Female
Key inclusion criteria 1. Liver function: Child A, B
2. WBC>2000
3. Plt>50000
4. Cr<3.0
5. Normal ECG
6. PS: 0, 1
7. Survival time>4 weeks
8. Tumor size and number: less than or equal 3cm and 3 or less than or equal 5cm and solitary
Key exclusion criteria 1. Patients with other malignancy
2. Pregnancy case
3. Patients with severe heart brain disease
Target sample size 5

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Fuminori Moriyasu
Organization Tokyo Medical University
Division name Gastroenterology and Hepatology
Zip code
Address 6-7-1, Nishishinjuku, Shinjuku-ku, Tokyo, Japan
TEL 03-3342-6111
Email moriyasu@tokyo-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Katsutoshi Sugimoto
Organization Tokyo Medical University
Division name Gastroenterology and Hepatology
Zip code
Address 6-7-1, Nishishinjuku, Shinjuku-ku, Tokyo, Japan
TEL 03-3342-6111
Homepage URL
Email sugimoto@tokyo-med.ac.jp

Sponsor
Institute Tokyo Medical University
Institute
Department

Funding Source
Organization Tokyo Medical University
Organization
Division
Category of Funding Organization Other
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
2014 Year 04 Month 16 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 No longer recruiting
Date of protocol fixation
2013 Year 12 Month 05 Day
Date of IRB
Anticipated trial start date
2014 Year 02 Month 01 Day
Last follow-up date
2015 Year 08 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 04 Month 16 Day
Last modified on
2014 Year 07 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016033

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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