UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050347 |
|---|---|
| Receipt number | R000057335 |
| Scientific Title | Usefulness of quantitative MRI in the evaluation of pancreatic fibrosis and evaluation of residual pancreatic exocrine function |
| Date of disclosure of the study information | 2023/03/01 |
| Last modified on | 2023/08/22 11:51:12 |
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Basic information
Public title
Usefulness of quantitative MRI in the evaluation of pancreatic fibrosis and evaluation of residual pancreatic exocrine function
Acronym
Usefulness of quantitative MRI in the evaluation of pancreatic fibrosis and evaluation of residual pancreatic exocrine function
Scientific Title
Usefulness of quantitative MRI in the evaluation of pancreatic fibrosis and evaluation of residual pancreatic exocrine function
Scientific Title:Acronym
Usefulness of quantitative MRI in the evaluation of pancreatic fibrosis and evaluation of residual pancreatic exocrine function
Region
| Japan |
Condition
Condition
pancreatic tumor
Classification by specialty
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the residual pancreatic exocrine function in cases after pancreatectomy using functional MRI non-invasively
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Elastase 1 concentration in stool after pancreatectomy
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who will have pancreatectomy in Kawasaki Medical School Hospital
Key exclusion criteria
Patients who will have total pancreatectomy
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Hidemitsu |
| Middle name | |
| Last name | Sotozono |
Organization
Kawasaki Medical School
Division name
Radiology(Diagnostic imaging)
Zip code
701-0192
Address
577 Matsushima, Kurashiki City, Okayama Prefecture
TEL
086-462-1111
mhaya@med.kawasaki-m.ac.jp
Public contact
Name of contact person
| 1st name | Hidemitsu |
| Middle name | |
| Last name | Sotozono |
Organization
Kawasaki Medical School
Division name
Radiology(Diagnostic imaging)
Zip code
701-0192
Address
577 Matsushima, Kurashiki City, Okayama Prefecture
TEL
086-462-1111
Homepage URL
sotozono@med.kawasaki-m.ac.jp
Sponsor or person
Institute
Kawasaki Medical School
Institute
Department
Personal name
Funding Source
Organization
Kawasaki Medical School
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
Kawasaki Medical School
Address
577 Matsushima, Kurashiki City, Okayama Prefecture
Tel
086-462-1111
kmsrec@med.kawasaki-m.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
| 2023 | Year | 03 | Month | 01 | 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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 02 | Month | 15 | Day |
Date of IRB
| 2023 | Year | 08 | Month | 08 | Day |
Anticipated trial start date
| 2023 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The purpose of this study is to establish a noninvasive method for the evaluation of pancreatic fibrosis and residual pancreatic exocrine function after pancreatic tumor surgery using non-contrast MRI before and after pancreatectomy by assessing changes in the pancreatic parenchyma and main pancreatic duct, the degree of pancreatic exocrine function, and comparing postoperative histopathologic findings of the parenchyma and the degree of fibrosis with pre- and postoperative stool elastase 1 This study aims to establish a non-invasive method to evaluate pancreatic fibrosis and residual pancreatic exocrine secretory capacity after pancreatic tumor surgery using non-contrast MRI.
Management information
Registered date
| 2023 | Year | 02 | Month | 15 | Day |
Last modified on
| 2023 | Year | 08 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057335
