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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000016423
Receipt No. 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

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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
Email 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
Email akihikot@tokyo-med.ac.jp

Sponsor
Institute Tokyo Medical University
Institute
Department

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
Email 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
URL(English) https://upload.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


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