UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020428 |
|---|---|
| Receipt number | R000023544 |
| Scientific Title | Assessment of liver pathogenesis by MR elastography for NAFLD after pancreatectomy |
| Date of disclosure of the study information | 2016/01/08 |
| Last modified on | 2016/01/15 10:56:12 |
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Basic information
Public title
Assessment of liver pathogenesis by MR elastography for NAFLD after pancreatectomy
Acronym
Assessment of liver pathogenesis by MR elastography for NAFLD after pancreatectomy (MRENAP STUDY)
Scientific Title
Assessment of liver pathogenesis by MR elastography for NAFLD after pancreatectomy
Scientific Title:Acronym
Assessment of liver pathogenesis by MR elastography for NAFLD after pancreatectomy (MRENAP STUDY)
Region
| Japan |
Condition
Condition
Patients scheduled to undergo pancreatectomy
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To prove that MR elastography is useful for diagnosis of liver pathogenesis in patients with NAFLD after pancreatectomy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To assess whether the shear modulus of liver measured by MR elastography is useful for diagnosis of liver fatty metacorphosis and fibrosis in patients with NAFLD after pancreatectomy.
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
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
To perform MR elastography in addition conventional examinations for assessment of fibrosis in patients scheduled to undergo pancreatectomy before and after operation
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients scheduled to undergo pancreatectomy at our institution, provide a written informed consent, and do not meet the below exclusion criteria.
Key exclusion criteria
(1)MRI examination is impossible (ex. metal in body, claustrophobia)
(2)Pregnant patients
(3) Uunsuitable patient as a study subject in the decision of the investigator.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ryutaro Mori |
Organization
Yokohama City University Graduate School of Medicine
Division name
Department of Gastroenterological Surgery
Zip code
Address
3-9 Fuku-ura, Kanazawa-ku, Yokohama, Kanagawa
TEL
045-787-2650
kouki_go_to@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Koki Goto |
Organization
Yokohama City University Graduate School of Medicine
Division name
Department of Gastroenterological Surgery
Zip code
Address
3-9 Fuku-ura, Kanazawa-ku, Yokohama, Kanagawa
TEL
045-787-2650
Homepage URL
kouki_go_to@yahoo.co.jp
Sponsor or person
Institute
Yokohama City University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Yokohama City University Graduate School of Medicine
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
Address
Tel
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 | 01 | Month | 08 | 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
| 2016 | Year | 01 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 01 | Month | 11 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 01 | Month | 04 | Day |
Last modified on
| 2016 | Year | 01 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023544
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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