UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000036686
Receipt No. 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 2019/05/08

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email sashina@med.kobe-u.ac.jp

Sponsor
Institute Kobe University
Institute
Department

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
Email 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
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 Preinitiation
Date of protocol fixation
2019 Year 05 Month 08 Day
Date of IRB
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
2019 Year 05 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041794

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.