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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000040676
Receipt No. 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

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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
Email 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
Email akira-y@dokkyomed.ac.jp

Sponsor
Institute Dokkyo Medical University School of Medicine
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046426

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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