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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000036719
Receipt No. R000041838
Scientific Title Retrospective comparison of gradient and spin echo sequence and compressed sensing reconstruction in breath-hold 3D magnetic resonance cholangiopancreatography
Date of disclosure of the study information 2019/05/20
Last modified on 2019/05/12

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Basic information
Public title Retrospective comparison of gradient and spin echo sequence and compressed sensing reconstruction in breath-hold 3D magnetic resonance cholangiopancreatography
Acronym Retrospective comparison of gradient and spin echo sequence and compressed sensing reconstruction in breath-hold 3D magnetic resonance cholangiopancreatography
Scientific Title Retrospective comparison of gradient and spin echo sequence and compressed sensing reconstruction in breath-hold 3D magnetic resonance cholangiopancreatography
Scientific Title:Acronym Retrospective comparison of gradient and spin echo sequence and compressed sensing reconstruction in breath-hold 3D magnetic resonance cholangiopancreatography
Region
Japan

Condition
Condition pancreato-biliary diseases
Classification by specialty
Hepato-biliary-pancreatic medicine Radiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare the image quality of single breath-hold 3D MRCP using GRASE with that of the compressed sensing.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Qualitative evaluation of visibility of the common bile duct
Key secondary outcomes Quantitative and qualitative evaluation of the bile duct segments

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 1) Cases suspected to be biliary or pancreatic diseases
2) Cases underwent MRCP with a MR system capable of compressed sensing reconstruction
Key exclusion criteria 1) Cases with unavailable MRCP images
2) Cases with multiple cysts or tumors in the liver
3) Cases with obstruction of the biliary and/or pancreatic duct due to tumor or stone
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Daisuke
Middle name
Last name Morimoto
Organization Kindai University Hospital
Division name Department of Central Radiology
Zip code 589-8511
Address 377-2 Ohno-higashi, Osaka-Sayama, Osaka
TEL 072-366-0221
Email morimoto-d@med.kindai.ac.jp

Public contact
Name of contact person
1st name Daisuke
Middle name
Last name Morimoto
Organization Kindai University Hospital
Division name Department of Central Radiology
Zip code 589-8511
Address 377-2 Ohno-higashi, Osaka-Sayama, Osaka
TEL 072-366-0221
Homepage URL http://radiol.med.kindai.ac.jp/news.html
Email morimoto-d@med.kindai.ac.jp

Sponsor
Institute Kindai University
Institute
Department

Funding Source
Organization Self Funding
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 Ethics Committee Kindai University Faculty of Medicine
Address 377-2 Ohno-higashi, Osaka-Sayama, Osaka
Tel 072-366-0221
Email zizen@med.kindai.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 近畿大学病院

Other administrative information
Date of disclosure of the study information
2019 Year 05 Month 20 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 Preinitiation
Date of protocol fixation
2019 Year 04 Month 18 Day
Date of IRB
2019 Year 05 Month 07 Day
Anticipated trial start date
2019 Year 05 Month 07 Day
Last follow-up date
2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information We will retrospectively assess the image quality of single breath-hold 3D MRCP using GRASE compared with that using the compressed sensing technique.

Management information
Registered date
2019 Year 05 Month 12 Day
Last modified on
2019 Year 05 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041838

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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