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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000008340
Receipt No. R000009613
Scientific Title pancreatic exocrine function with non-contrast MRI:Visualization by Means of MRCP with Spatially Selective Inversion-Recovery Pulse
Date of disclosure of the study information 2012/07/04
Last modified on 2015/07/20

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Basic information
Public title pancreatic exocrine function with non-contrast MRI:Visualization by Means of MRCP with Spatially Selective Inversion-Recovery Pulse
Acronym pancreatic exocrine function using non-contrast MRI
Scientific Title pancreatic exocrine function with non-contrast MRI:Visualization by Means of MRCP with Spatially Selective Inversion-Recovery Pulse
Scientific Title:Acronym pancreatic exocrine function using non-contrast MRI
Region
Japan

Condition
Condition Chronic pancreatitis
Classification by specialty
Hepato-biliary-pancreatic medicine Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 That visualized by imaging MRCP with time-spatial labeling inversion pulse(Cine dynamic MRCP images) the flow of pancreatic juice, to examine the correlation between the test PFD, may be able to establish a method for performance evaluation of the exocrine pancreas simple non-invasive.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To evaluation of the correlation between the flow of pancreatic juice in the pancreatic duct using Cine dynamic MRCP images and PFD test.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Diagnosis
Type of intervention
Medicine
Interventions/Control_1 MRCP/PFD test
Interventions/Control_2 MRCP
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1; healthy volunteer
cognitive normal subjects without severe physical complication.

2; Chronic pancreatitis
Patients with chronic pancreatitis have already done the PFD.
Key exclusion criteria subject with claustrophobia who cannot perform MRI examination.
subject who has metal such as pacemaker in the body, and cannot perform MRI examination.
subjects with tattoo.
exclude the patients who are recognized as inadequate patients by doctors with responsibility in this study.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akira Yamamoto
Organization Kawasaki Medical School
Division name the Department of Diagnostic Radiology
Zip code
Address 577 Matushima, Kurashiki, Okayama, Japan
TEL 086-462-1111
Email akira.yamamoto0420@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Kazuya Yasokawa
Organization Kawasaki Medical School
Division name the Department of Diagnostic Radiology
Zip code
Address 577 Matushima, Kurashiki, Okayama, Japan
TEL 086-462-1111
Homepage URL
Email roentgen@med.kawasaki-m.ac.jp

Sponsor
Institute the Department of Diagnostic Radiology Kawasaki Medical School
Institute
Department

Funding Source
Organization Kawasaki Medical School
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
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

Other administrative information
Date of disclosure of the study information
2012 Year 07 Month 04 Day

Related information
URL releasing protocol
Publication of results Published

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
2012 Year 06 Month 25 Day
Date of IRB
Anticipated trial start date
2012 Year 08 Month 01 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
2012 Year 07 Month 04 Day
Last modified on
2015 Year 07 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009613

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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