UMIN-CTR Clinical Trial

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

malabsorption syndrome

Classification by specialty

Radiology

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Kawasaki Medical School

Institute

Department

Personal name

Organization

MEXT KAKENHI Grant

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2016

Year

11

Month

14

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2016

Year

11

Month

14

Day

Last modified on

2017

Year

05

Month

08

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018818