UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030066 |
|---|---|
| Receipt number | R000034332 |
| Scientific Title | Evaluation of the correlation between endoscopic ultrasonography findings of the pancreas and pancreatic endo/exocrine function |
| Date of disclosure of the study information | 2017/12/01 |
| Last modified on | 2022/05/26 14:30:39 |
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Basic information
Public title
Evaluation of the correlation between endoscopic ultrasonography findings of the pancreas and pancreatic endo/exocrine function
Acronym
Evaluation of the correlation between endoscopic ultrasonography findings of the pancreas and pancreatic endo/exocrine function
Scientific Title
Evaluation of the correlation between endoscopic ultrasonography findings of the pancreas and pancreatic endo/exocrine function
Scientific Title:Acronym
Evaluation of the correlation between endoscopic ultrasonography findings of the pancreas and pancreatic endo/exocrine function
Region
| Japan |
Condition
Condition
early chronic pancreatitis
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify whether endoscopic ultrasonography findings seen in early chronic pancreatitis are related to pancreatic endo/exocrine function.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Correlation between endoscopic ultrasonography
findings seen in early chronic pancreatitis and pancreatic endo/exocrine function
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 understand the examination contents and obtain consent to the examination
Key exclusion criteria
Patients who do not accept the examination
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Takayuki |
| Middle name | |
| Last name | Watanabe |
Organization
Shinshu University
Division name
Department of Gastroenterology
Zip code
390-8621
Address
3-1-1, Asahi, Matsumoto City, Nagano Prefecture
TEL
0263-37-2634
wat1400@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | Takayuki |
| Middle name | |
| Last name | Watanabe |
Organization
Shinshu University
Division name
Department of Gastroenterology
Zip code
390-8621
Address
3-1-1, Asahi, Matsumoto City, Nagano Prefecture
TEL
0263-37-2634
Homepage URL
wat1400@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu University
Institute
Department
Personal name
Funding Source
Organization
Takeda Pharmaceutical Company Limited
Takeda reserch support
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
Shinshu University Certified Review Board of Clinical Research
Address
3-1-1 Asahi, Matsumoto, Nagano
Tel
0263-37-2572
mdrinri@shinshu-u.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
| 2017 | Year | 12 | 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
131
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
Main results already published
Date of protocol fixation
| 2017 | Year | 10 | Month | 03 | Day |
Date of IRB
| 2017 | Year | 10 | Month | 03 | Day |
Anticipated trial start date
| 2017 | Year | 10 | Month | 03 | Day |
Last follow-up date
| 2022 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Without intervention, observational study.
We clarify whether endoscopic ultrasonography findings seen in early chronic pancreatitis are related to pancreatic endo/exocrine function, and which finding is most correlate.
Management information
Registered date
| 2017 | Year | 11 | Month | 21 | Day |
Last modified on
| 2022 | Year | 05 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034332
