UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027763 |
|---|---|
| Receipt number | R000031814 |
| Scientific Title | New diagnosing method for early chronic pancreatitis: Application of MRI elastography |
| Date of disclosure of the study information | 2017/06/26 |
| Last modified on | 2020/02/21 11:28:37 |
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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
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
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
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
junryuhei@belle.shiga-med.ac.jp
Sponsor or person
Institute
Shiga University of Medical Science
Institute
Department
Personal name
Funding Source
Organization
Shiga University of Medical Science
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031814
