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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000009969
Receipt No. R000011664
Scientific Title The research of establishment of therapeutic method and safety in High-Intensity Focused Ultrasound (HIFU) therapy for unresectable pancreatic cancer
Date of disclosure of the study information 2013/02/05
Last modified on 2017/02/08

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Basic information
Public title The research of establishment of therapeutic method and safety in High-Intensity Focused Ultrasound (HIFU) therapy for unresectable pancreatic cancer
Acronym The research of HIFU therapy for unresectable pancreas cancer
Scientific Title The research of establishment of therapeutic method and safety in High-Intensity Focused Ultrasound (HIFU) therapy for unresectable pancreatic cancer
Scientific Title:Acronym The research of HIFU therapy for unresectable pancreas cancer
Region
Japan

Condition
Condition pancreatic cancer
Classification by specialty
Hepato-biliary-pancreatic medicine Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to evaluate the safety in HIFU therapy for unresectable pancreatic cancer and establish HIFU therapeutic method for pancreatic cancer.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase I,II

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

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
Interventions/Control_1 HIFU equipment:FEP-BY02(China Medical Tecnologies Co.)
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
90 years-old >
Gender Male and Female
Key inclusion criteria * age >20 years old
* WBC > 2000
Plt >5
Cre > 3.0 mg/dl
*Normal EKG
*PS: 0~3
*Survival time > 4 weeks
Key exclusion criteria *The patients with other malignancy
*Pregnancy case
*Obstructive Jaundice
*The patients with severe heart and brain disease
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Atsushi Sofuni
Organization Tokyo Medical University
Division name Gastroenterology and Hapatology
Zip code
Address 6-7-1 Nishishinjuku Shinjuku-ku 160-0023 Tokyo Japan
TEL 03-3342-6111
Email naika4@tokyo-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Atsushi Sofuni
Organization Tokyo Medical University
Division name Gastroenterology and hepatology
Zip code
Address 6-7-1 Nisishinjuku Shinjyuku-ku 160-0023
TEL 03-3342-6111
Homepage URL
Email a-sofuni@amy.hi-ho.ne.jp

Sponsor
Institute Tokyo Medical University
Dept.of Gastroenterology and hepatology
Institute
Department

Funding Source
Organization Cancer therapy research group of 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 東京医科大学 消化器内科
Tokyo Medical University Dept. of Gastroenterology and hapatology

Other administrative information
Date of disclosure of the study information
2013 Year 02 Month 05 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 Open public recruiting
Date of protocol fixation
2013 Year 02 Month 05 Day
Date of IRB
Anticipated trial start date
2013 Year 02 Month 05 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
2013 Year 02 Month 05 Day
Last modified on
2017 Year 02 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011664

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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