UMIN-CTR Clinical Trial

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	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000041794