UMIN-CTR Clinical Trial

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/icdr_e/ctr_view.cgi?recptno=R000019070