UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000036719
Receipt number 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 2021/11/11 21:06:29

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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 or person

Institute

Kindai University

Institute

Department

Personal name



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

Completed

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

2021 Year 11 Month 11 Day



Link to view the page

Value
https://center6.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