UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036686 |
|---|---|
| Receipt number | R000041794 |
| Scientific Title | Elucidation of disease by outflow dynamics imaging of bile and pancreatic fluid using cinedynamic MRI |
| Date of disclosure of the study information | 2019/05/10 |
| Last modified on | 2022/05/31 19:42:51 |
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Basic information
Public title
Elucidation of disease by outflow dynamics imaging of bile and pancreatic fluid using cinedynamic MRI
Acronym
Elucidation of disease by outflow dynamics imaging of bile and pancreatic fluid using cinedynamic MRI
Scientific Title
Elucidation of disease by outflow dynamics imaging of bile and pancreatic fluid using cinedynamic MRI
Scientific Title:Acronym
Elucidation of disease by outflow dynamics imaging of bile and pancreatic fluid using cinedynamic MRI
Region
| Japan |
Condition
Condition
Chronic pancreatitis, Autoimmune pancreatitis,Sphincter of Oddi dysfunction
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In patients with suspected biliary and pancreatic fluid outflow disorders (pathology), use cinedynamic MRI to investigate whether pancreatic fluid and biliary outflow disorders can be diagnosed.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Comparison of biliary and pancreatic fluid outflow in cinedynamic MRCP in healthy volunteer groups and disease groups suspected of biliary and pancreatic fluid outflow disorders.
Key secondary outcomes
Evaluation of outflow capacity according to disease. Diagnosis and evaluation after duodenal papillary sphincter dysfunction.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
One MRI examination is performed on a group of healthy volunteers.
Interventions/Control_2
Disease group is usually examined in the medical practice.
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
| 15 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients suspected of bile or pancreatic fluid outflow disorder by other imaging tests.
Patients who obtained written consent by their own intention about participation in this study.
Key exclusion criteria
Patients whose MRI images are difficult to evaluate due to artifacts.
Patients who could not carry out MRI examination for some reason.
Patients who were judged inappropriate by the person in charge of this study.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Atsuhiro |
| Middle name | |
| Last name | Masuda |
Organization
Kobe University
Division name
Gastroenterology
Zip code
650-0017
Address
7-5-1 Kusunoki-cho,Chuo-ku,Kobe,650-0017,Japan
TEL
078-382-6305
atmasuda@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Shigeto |
| Middle name | |
| Last name | Ashina |
Organization
Kobe University
Division name
Gastroenterology
Zip code
650-0017
Address
7-5-1 Kusunoki-cho,Chuo-ku,Kobe,650-0017,Japan
TEL
078-382-6305
Homepage URL
sashina@med.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University
Institute
Department
Personal name
Funding Source
Organization
Kobe 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
Kobe University
Address
7-5-1 Kusunoki-cho,Chuo-ku,Kobe,650-0017,Japan
Tel
078-382-6669
kainyu@med.kobe-u.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
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 05 | Month | 10 | 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
32
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
| 2019 | Year | 05 | Month | 08 | Day |
Date of IRB
| 2019 | Year | 10 | Month | 31 | Day |
Anticipated trial start date
| 2019 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 05 | Month | 08 | Day |
Last modified on
| 2022 | Year | 05 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041794
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
