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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000038565
Receipt No. R000043899
Scientific Title Interobserver agreement for detection of malignant features of IPMNs
Date of disclosure of the study information 2020/04/01
Last modified on 2021/05/15

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Basic information
Public title Interobserver agreement for
detection of malignant features
of IPMNs
Acronym Interobserver agreement for
detection of malignant features
of IPMNs
Scientific Title Interobserver agreement for
detection of malignant features
of IPMNs
Scientific Title:Acronym Interobserver agreement for
detection of malignant features
of IPMNs
Region
Japan

Condition
Condition Intraductal Papillary Mucinous
Neoplasms (IPMN)
Classification by specialty
Medicine in general Hepato-biliary-pancreatic medicine Surgery in general
Hepato-biliary-pancreatic surgery Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The purpose of this retrospective study was to measure interobserver agreement in the assessment of malignant imaging features of IPMNs.
Basic objectives2 Others
Basic objectives -Others The purpose of this retrospective study was to measure interobserver agreement in the assessment of malignant imaging features of IPMNs.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Interobserver agreement of lesion features malignant imaging features of IPMN.
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
90 years-old >=
Gender Male and Female
Key inclusion criteria Patients were selected who met a CT with multiphasic pancreatic protocol.
Key exclusion criteria Our exclusion criteria were as follows:emergency case, history of an adverse reaction to iodinated contrast media, and proved or suspected pregnancy.
Target sample size 70

Research contact person
Name of lead principal investigator
1st name Akio
Middle name
Last name Tamura
Organization Iwate Medical University
Division name Depertment of Radiology
Zip code 020-8505
Address 19-1, Uchimaru, Morioka
TEL 0196515111
Email a.akahane@gmail.com

Public contact
Name of contact person
1st name Akio
Middle name
Last name Tamura
Organization Iwate Medical University
Division name Depertment of Radiology
Zip code 020-8505
Address 19-1, Uchimaru, Morioka
TEL 0196515111
Homepage URL
Email a.akahane@gmail.com

Sponsor
Institute Iwate Medical University
Institute
Department

Funding Source
Organization Iwate Medical University
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 Iwate Medical University
Address 19-1, Uchimaru, Morioka
Tel +81196515111
Email a.akahane@gmail.com

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 04 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 No longer recruiting
Date of protocol fixation
2019 Year 11 Month 10 Day
Date of IRB
2020 Year 02 Month 27 Day
Anticipated trial start date
2020 Year 04 Month 02 Day
Last follow-up date
2021 Year 04 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information none

Management information
Registered date
2019 Year 11 Month 13 Day
Last modified on
2021 Year 05 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043899

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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