UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016423 |
|---|---|
| Receipt number | R000019070 |
| Scientific Title | The assessment of efficacy and safety of Irreversible Electroporation(IRE) to treat unresectable locally advanced pancreatic cancer |
| Date of disclosure of the study information | 2015/02/02 |
| Last modified on | 2019/08/07 17:38:17 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
The assessment of efficacy and safety of Irreversible Electroporation(IRE) to treat unresectable locally advanced pancreatic cancer
Acronym
IRE to treat unresectable locally advanced pancreatic cancer
Scientific Title
The assessment of efficacy and safety of Irreversible Electroporation(IRE) to treat unresectable locally advanced pancreatic cancer
Scientific Title:Acronym
IRE to treat unresectable locally advanced pancreatic cancer
Region
| Japan |
Condition
Condition
Unresectable locally advanced pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Effectiveness of IRE for treatment of unresectable locally advanced pancreatic cancer
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Effectiveness of IRE for treatmetn of unresectable locally advanced pancreatic cancer according to local control rate using CT or MRI performed 6 months after treatment
Key secondary outcomes
Incidence and kind of adverse events of up to 1 month after treatment
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Maneuver |
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. It does not matter whether the pre-treatment but it is necessary that 4 weeks was passed from the pre- treatment
2. It has been confirmed pathologically is adenocarcinoma or adenosquamous carcinoma
3. Patient of unresectable locally advanced pancreatic cancer (no distant metastasis, impossible reconstruction of PV/SMV obstruction, more than 180 degrees SMA/CeA invasion, Ao invasion)
4. Major organs (heart, lung, kidney, liver, etc.) function are maintained
a Child-Pugh class A or B
b WBC > 2000/L
c Platelet count > 50000/l
d Prothrombin time > 50%
e Cr<3.0mg/dl
f Total bilirubin level < 3mg/dl
g Cardiac function is normal
5. ECOG score 0 or 1
6. Life expectancy of at least 4 weeks
7. Written informed consent
Key exclusion criteria
1. distant metastasis,
2. CT or MRI contrast agent allergy,
3. Another organs malignancy,
4. Pregnant women or women of childbearing potential not using an acceptable method of contraception,
5. Uncontrolled infection
6. Heart failure, coronary artery disease or arrhythmia in progress, active implantable devices (eg pacemaker)
7 Patient's disability to stop anticoagulant and anti platelet therapy
8. Attending physician determines that inappropriate
Target sample size
6
Research contact person
Name of lead principal investigator
| 1st name | Akihiko |
| Middle name | |
| Last name | Tsuchida |
Organization
Tokyo Medical University
Division name
Gastrointestinal and pediatric surgery
Zip code
160-0023
Address
6-7-1, Nishishinjyuku, Shinjyuku-ku, Tokyo, Japan
TEL
03-3342-6111
akihikot@tokyo-med.ac.jp
Public contact
Name of contact person
| 1st name | Akihiko |
| Middle name | |
| Last name | Tsuchida |
Organization
Tokyo Medical University
Division name
Gastrointestinal and pediatric surgery
Zip code
160-0023
Address
6-7-1, Nishishinjyuku, Shinjyuku-ku, Tokyo, Japan
TEL
03-3342-6111
Homepage URL
akihikot@tokyo-med.ac.jp
Sponsor or person
Institute
Tokyo Medical University
Institute
Department
Personal name
Funding Source
Organization
Tokyo medical university, Gastrointestinal and pediatric surgery, Gastroenterology and Hepatology
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Medical University
Address
6-7-1, Nishishinjyuku, Shinjyuku-ku, Tokyo
Tel
0333426111
kazu-k@tokyo-med.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
東京医科大学病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 02 | Month | 02 | 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
Completed
Date of protocol fixation
| 2014 | Year | 05 | Month | 15 | Day |
Date of IRB
| 2014 | Year | 03 | Month | 31 | Day |
Anticipated trial start date
| 2015 | Year | 02 | Month | 03 | Day |
Last follow-up date
| 2017 | Year | 06 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 02 | Month | 02 | Day |
Last modified on
| 2019 | Year | 08 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019070
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
