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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024819
Receipt No. R000018818
Scientific Title Evaluation of change in flow of bile, pancreatic juice and lymph under secretion stimulation with non-contrast MR imaging using Time SLIP
Date of disclosure of the study information 2016/11/14
Last modified on 2017/05/08

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Basic information
Public title Evaluation of change in flow of bile, pancreatic juice and lymph under secretion stimulation with non-contrast MR imaging using Time SLIP
Acronym Change in flow of bile, pancreatic juice and lymph under secretion stimulation with non-contrast MRI
Scientific Title Evaluation of change in flow of bile, pancreatic juice and lymph under secretion stimulation with non-contrast MR imaging using Time SLIP
Scientific Title:Acronym Change in flow of bile, pancreatic juice and lymph under secretion stimulation with non-contrast MRI
Region
Japan

Condition
Condition malabsorption syndrome
Classification by specialty
Radiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the cause of malabsorption syndrome and chronic pancreatitis with non-invasive methods using non-contrast MRI
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes MRCP images using Time SLIP were evaluated for the presence, frequency, and magnitude of bile, pancreatic juice and lymph inflow within the tagged area.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Food
Interventions/Control_1 lemon juice was given peroral before MRI examinatin
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
100 years-old >
Gender Male and Female
Key inclusion criteria Patient who have abdominal symptoms
Key exclusion criteria Excluding patients whose abdominal symptoms improved after they were prescribed drugs for those symptoms
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akira Yamamoto
Organization Kawasaki Medical School
Division name Diagnostic Radiology
Zip code
Address 577 Matsushima Kurashiki Okayama JAPAN
TEL 086-462-1111
Email jiro@med.kawasaki-m.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Akira Yamamoto
Organization Kawasaki Medical School
Division name Diagnostic Radiology
Zip code
Address 577 Matsushima Kurashiki Okayama JAPAN
TEL 086-462-1111
Homepage URL
Email jiro@med.kawasaki-m.ac.jp

Sponsor
Institute Kawasaki Medical School
Institute
Department

Funding Source
Organization MEXT KAKENHI Grant
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2016 Year 11 Month 14 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
Objective:
In a previous study, we demonstrated that a quantitative evaluation of exocrine pancreatic function could be performed noninvasively using cine-dynamic magnetic resonance cholangiopancreatography (MRCP). The purpose of the present study was to elucidate the relationship between exocrine pancreatic function, as evaluated using cine-dynamic MRCP, and abdominal symptoms.

Materials and Methods:
Cine-dynamic MRCP was performed and an 18-item questionnaire on abdominal symptoms was administered to 103 patients with various types of abdominal symptoms. Excluding patients whose abdominal symptoms improved after they were prescribed drugs for those symptoms, 42 patients were eventually included in the study. Cine-dynamic MRCP evaluations were performed with the agreement of 2 radiologists. The relationship between exocrine pancreatic function, which was quantified as an exocrine pancreatic score, and the abdominal symptoms for the 18 questionnaire items was assessed.

Results:
Symptoms for 3 of the 18 abdominal symptom items were significantly associated with decreased exocrine pancreatic function, as measured by cine-dynamic MRCP: item 9, flatus smells worse than usual; item 13, stool quantity is large; and item 18, stools are soft. No significant correlation with exocrine pancreatic function measured by cine-dynamic MRCP was seen for the remaining 15 abdominal symptom items.

Conclusion:
The abdominal symptoms for the 3 items indicated in the results are symptoms that are more likely to appear as a result of decreased exocrine pancreatic function. If a patient complains of such symptoms, the possibility of decreased exocrine pancreatic function should be considered, and such function should be aggressively evaluated by cine-dynamic MRCP.

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 Completed
Date of protocol fixation
2015 Year 02 Month 01 Day
Date of IRB
Anticipated trial start date
2015 Year 03 Month 27 Day
Last follow-up date
2017 Year 01 Month 31 Day
Date of closure to data entry
2017 Year 01 Month 31 Day
Date trial data considered complete
2017 Year 01 Month 31 Day
Date analysis concluded
2017 Year 01 Month 31 Day

Other
Other related information

Management information
Registered date
2016 Year 11 Month 14 Day
Last modified on
2017 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=R000018818

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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