UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040676 |
|---|---|
| Receipt number | R000046426 |
| Scientific Title | The Evaluation of Interobserver reliability in the Diagnostic Criteria for Early Chronic Pancreatitis 2019 |
| Date of disclosure of the study information | 2020/06/06 |
| Last modified on | 2020/06/06 17:14:00 |
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Basic information
Public title
The Evaluation of Interobserver reliability in the Diagnostic Criteria for Early Chronic Pancreatitis 2019
Acronym
The Evaluation of Interobserver reliability in the Diagnostic Criteria for Early Chronic Pancreatitis 2019
Scientific Title
The Evaluation of Interobserver reliability in the Diagnostic Criteria for Early Chronic Pancreatitis 2019
Scientific Title:Acronym
The Evaluation of Interobserver reliability in the Diagnostic Criteria for Early Chronic Pancreatitis 2019
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 compare the interobserver reliability of EUS criteria for diagnosis of ECP in diagnostic criteria2009 with diagnostic criteria2019.
Basic objectives2
Others
Basic objectives -Others
Validating the interobserver reliability of each EUS finding in diagnostic criteria2009 and diagnostic criteria2019
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparing the interobserver reliability of EUS criteria for diagnosis of ECP in diagnostic criteria2009 with diagnostic criteria2019.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The patients with one or more EUS diagnostic findings of early chronic pancreatitis based on diagnostic criteria2009
Key exclusion criteria
The cases with pancreatic tumor, definite chronic pancreatitis, and probable chronic pancreatitis at the time of diagnosis were excluded.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Akira |
| Middle name | |
| Last name | Yamamiya |
Organization
Dokkyo Medical University School of Medicine
Division name
Department of Gastroenterology
Zip code
321-0293
Address
880 Kitakobayashi Mibu Tochigi 321-0293, Japan.
TEL
0282872147
akira-y@dokkyomed.ac.jp
Public contact
Name of contact person
| 1st name | Akira |
| Middle name | |
| Last name | Yamamiya |
Organization
Dokkyo Medical University School of Medicine
Division name
Department of Gastroenterology
Zip code
321-0293
Address
880 Kitakobayashi Mibu Tochigi 321-0293, Japan.
TEL
0282872147
Homepage URL
akira-y@dokkyomed.ac.jp
Sponsor or person
Institute
Dokkyo Medical University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Dokkyo Medical University 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
Dokkyo Medical University School of Medicine
Address
880 Kitakobayashi Mibu Tochigi 321-0293, Japan.
Tel
0282872147
0282867761
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
| 2020 | Year | 06 | Month | 06 | 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
| 2019 | Year | 08 | Month | 04 | Day |
Date of IRB
| 2019 | Year | 08 | Month | 04 | Day |
Anticipated trial start date
| 2019 | Year | 08 | Month | 04 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2020 | Year | 06 | Month | 06 | Day |
Last modified on
| 2020 | Year | 06 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046426
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
