UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014522 |
|---|---|
| Receipt number | R000016844 |
| Scientific Title | The assessment of efficacy and safety of Irreversible Electroporation(IRE) to treat hepatic malignancies |
| Date of disclosure of the study information | 2014/07/09 |
| Last modified on | 2014/07/24 09:40:33 |
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Basic information
Public title
The assessment of efficacy and safety of Irreversible Electroporation(IRE) to treat hepatic malignancies
Acronym
IRE to treat hepatic malignancies
Scientific Title
The assessment of efficacy and safety of Irreversible Electroporation(IRE) to treat hepatic malignancies
Scientific Title:Acronym
IRE to treat hepatic malignancies
Region
| Japan |
Condition
Condition
Hepatocellular carcinoma, metastatic liver cancer, cholangiocarcinoma
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Effectiveness of IRE for treatment of hepatic malignancies
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Effectiveness of IRE for treatmetn of hepatic malignancies according to modified RECIST criteria using CT or MRI performed 6 months after treatment.
Key secondary outcomes
Safety within 30 days post-intervention. All adverse events will be classified according to CTCAE version 4.0 criteria.
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. Older than 20 years,
2. Male or female,
3. Diagnosis of hepatocellular carcinoma, metastatic liver cancer or cholangiocarcinoma based on positive biopsy or noninvasive criteria,
4. Not suitable for surgical resection and patients who are not willing ot surgical resection,
5. Primary tumor is controlled,
6. The target nodule must have a diammeter of <= 10 cm,
7. Child-Pugh class A,
8. Platelet count > 50X10*9/L
9. Liver lesion visible on US, CT, or MRI,
10. ECOG score 0, 1,
11. ASA score <= 3,
12. Life expectancy of at least 12 weeks,
13, Written informed consent,
Key exclusion criteria
1. Uncontrolled infection,
2. Heart failure, coronary artery disease or arrhythmia in progress, active implantable devices (eg pacemaker),
3. Pregnant women or women of childbearing potential not using an acceptable method of contraception,
4. Patient's disability to stop anticoagulant and antiplatelet therapy,
5. In the opinion of the researcher, anyone who cannot follow the calender of vist and asessment of the Protocol,
6. Patient received systemic chemotherapy within 4 weeks of treatment with the IRE NanoKnife,
Target sample size
20
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
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
sugimoto@tokyo-med.ac.jp
Sponsor or person
Institute
Tokyo Medical University
Institute
Department
Personal name
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
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
東京医科大学病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 07 | Month | 09 | 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
Enrolling by invitation
Date of protocol fixation
| 2014 | Year | 05 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 07 | Month | 10 | 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
| 2014 | Year | 07 | Month | 09 | Day |
Last modified on
| 2014 | Year | 07 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016844
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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