UMIN-CTR Clinical Trial

Basic information
Public title	New diagnosing method for early chronic pancreatitis: Application of MRI elastography
Acronym	Application of MRI elastography for early chronic pancreatitis
Scientific Title	New diagnosing method for early chronic pancreatitis: Application of MRI elastography
Scientific Title:Acronym	Application of MRI elastography for early chronic pancreatitis
Region	Japan

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

Objectives
Narrative objectives1	To compare normal pancreas, early chronic pancreatitis and chronic pancreatitis using MRI elastography and to diagnose early chronic pancreatitis noninvasively and quantitatively.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Evaluate the items below. A. pancreatic elasticity of head, body part, tail part B. optimal cutoff value among 3 groups C. sensitivity and specificity D. the diagnostic ability of pancreatic fibrosis of MR elastography
Key secondary outcomes	Coincidence ratio and reproducibility of measured values by two evaluators

Base
Study type	Others,meta-analysis etc

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	A. Patients who are diagnosed as early chronic pancreatitis B. Patients who are diagnosed as chronic pancreatitis C. Patients who are diagnosed as normal pancreas D. Patients on whom MRCP are performed E. Patients can hold the breath in a supine position F. Patients can consent the study
Key exclusion criteria	A. Patient during pregnancy. B. Patient who the doctor in charge considers inappropriate as the subject of this study C. Underage D. Patients who can not perform MRI because of pacemakers or tattoos
Target sample size	90

Research contact person
Name of lead principal investigator	1st name Middle name Last name Shinichi Ota
Organization	Shiga University of Medical Science
Division name	Department of Radiology
Zip code
Address	Seta Tsukinowa-cho, Otsu city, Shiga
TEL	077-548-2288
Email	junryuhei@belle.shiga-med.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Shinichi Ota
Organization	Shiga University of Medical Science
Division name	Department of Radiology
Zip code
Address	Seta Tsukinowa-cho, Otsu city, Shiga
TEL	077-548-2288
Homepage URL
Email	junryuhei@belle.shiga-med.ac.jp

Sponsor
Institute	Shiga University of Medical Science
Institute
Department

Funding Source
Organization	Shiga University of Medical Science
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	Japan

Other related organizations
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IRB Contact (For public release)
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Address
Tel
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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	滋賀医科大学病院

Other administrative information
Date of disclosure of the study information	2017 Year 06 Month 26 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
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Results
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Baseline Characteristics
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Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2017 Year 07 Month 30 Day
Date of IRB
Anticipated trial start date	2017 Year 09 Month 08 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	2017 Year 06 Month 14 Day
Last modified on	2020 Year 02 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031814