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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000028455
Receipt No. R000032580
Scientific Title Usefulness of Dispersion Evaluation in the Pancreatic Diseases
Date of disclosure of the study information 2017/08/01
Last modified on 2018/08/01

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Basic information
Public title Usefulness of Dispersion Evaluation in the Pancreatic Diseases
Acronym DEP-study
Scientific Title Usefulness of Dispersion Evaluation in the Pancreatic Diseases
Scientific Title:Acronym DEP-study
Region
Japan

Condition
Condition pancreatic diseases
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the elasticity and dispersion of pancreatic diseases using ultrasonographic elastography and compare the results with histopathological findings.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Correlation between Shear wave elastography (Shear wave speed and Shear wave dispertion) and histopathological findings.
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 Preservation of main
organ functions at the time of diagnosis.
Provision of written consent to participate in the study.
Key exclusion criteria Serious complications.
Severe mental disorder.
Judgment as being ineligible by the principal or subinvestigator.
Target sample size 150

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Yoshiki Hirooka
Organization Nagoya University Hospital
Division name Department of Endoscopy
Zip code
Address 65 Tsurumai-cho, Showa-ku, Nagoya, 466-8550
TEL 052-744-2602
Email hirooka@med.nagoya-u.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Takuya Ishikawa
Organization Nagoya University Graduate School of Medicine
Division name Department of Gastroenterology
Zip code
Address 65 Tsurumai-cho, Showa-ku, Nagoya, 466-8550
TEL 052-744-2602
Homepage URL
Email ishitaku@med.nagoya-u.ac.jp

Sponsor
Institute Nagoya University
Institute
Department

Funding Source
Organization Nagoya University
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 08 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 Enrolling by invitation
Date of protocol fixation
2017 Year 09 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 10 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Nothing specific

Management information
Registered date
2017 Year 07 Month 31 Day
Last modified on
2018 Year 08 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032580

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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