UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of change in flow of bile, pancreatic juice and lymph under secretion stimulation with non-contrast MR imaging using Time SLIP
Title of the study (Brief title)	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	Akira Yamamoto
Organization	Kawasaki Medical School
Division name	Diagnostic Radiology
Address	577 Matsushima Kurashiki Okayama JAPAN
TEL	086-462-1111
Email	jiro@med.kawasaki-m.ac.jp

Public contact
Name of contact person	Akira Yamamoto
Organization	Kawasaki Medical School
Division name	Diagnostic Radiology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 02 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
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.
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