UMIN-CTR Clinical Trial

Unique ID issued by UMIN	UMIN000033423
Receipt number	R000038097
Scientific Title	Validity of 3D magnetic resonance cholangiopancreatography with combined parallel imaging and compressed sensing reconstruction at 1.5 Tesla
Date of disclosure of the study information	2018/07/17
Last modified on	2020/01/16 16:19:47

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Basic information

Public title

Validity of 3D magnetic resonance cholangiopancreatography with combined parallel imaging and compressed sensing reconstruction at 1.5 Tesla

Acronym

3D MRCP with combined parallel imaging and compressed sensing reconstruction

Scientific Title

Validity of 3D magnetic resonance cholangiopancreatography with combined parallel imaging and compressed sensing reconstruction at 1.5 Tesla

Scientific Title:Acronym

3D MRCP with combined parallel imaging and compressed sensing reconstruction

Region

Japan

Condition

pancreato-biliary diseases

Classification by specialty

Hepato-biliary-pancreatic medicine Radiology

Classification by malignancy

Others

Genomic information

Objectives

Narrative objectives1

To validate the effect of combined parallel imaging and compressed sensing reconstruction on 3D MRCP.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Assessment

Primary outcomes

Visibility of the common bile duct

Key secondary outcomes

Visibility of the other bile ducts
Acquisition time

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 biliary or pancreatic disease who require MRCP
2) Cases underwent MRCP with combined parallel imaging and compressed sensing reconstruction at 1.5T MRI system
3) Cases with informed consent

Key exclusion criteria

1) Inadequate image quality due to patient factor or failure of equipment
2) Cases with multiple cysts or malignant tumors in the liver
3) Cases with obstruction of the biliary and/or pancreatic duct due to tumor or stone

Target sample size

Research contact person

Name of lead principal investigator

1st name Tomoko

Middle name

Last name Hyodo

Organization

Kindai University Faculty of Medicine

Division name

The Department of Radiology

Zip code

589-8511

Address

377-2 Ohno-higashi, Osaka-Sayama, Osaka 589-8511

TEL

072-366-0221

Email

thyodo@med.kindai.ac.jp

Public contact

Name of contact person

1st name Tomoko

Middle name

Last name Hyodo

Organization

Kindai University Faculty of Medicine

Division name

The Department of Radiology

Zip code

589-8511

Address

377-2 Ohno-higashi, Osaka-Sayama, Osaka 589-8511

TEL

072-366-0221

Homepage URL

http://radiol.med.kindai.ac.jp/news.html

Email

thyodo@med.kindai.ac.jp

Sponsor or person

Institute

Kindai University Faculty of Medicine

Institute

Department

Personal name

Funding Source

Organization

None

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

Ethics Committee Kindai University Faculty of Medicine

Address

377-2 Ohno-higashi, Osaka-Sayama, Osaka 589-8511

Tel

072-366-0221(3756)

Email

zizen@med.kindai.ac.jp

Secondary IDs

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

近畿大学医学部附属病院

Other administrative information

Date of disclosure of the study information

2018 Year 07 Month 17 Day

Related information

URL releasing protocol

http://upload.umin.ac.jp/rd/rd.cgi?t=ic&n=R000038097&k=10032ZG4Wbm63szcakUOKn08

Publication of results

Published

Result

URL related to results and publications

http://dx.doi.org/10.1007/s00261-020-02403-y

Number of participants that the trial has enrolled

Results

Using NT C-SENSE and BH C-SENSE for MRCP reduces the acquisition time. Although their use causes a significantly inferior visualization score of the intrahepatic duct, the following analyses showed that the image quality was not inferior to that obtained with NT SENSE at 1.5-T. In addition, the image availability of NT C-SENSE and BH C-SENSE depends on individual-related factors such as age.

Results date posted

2020 Year 01 Month 16 Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

2020 Year 01 Month 10 Day

Baseline Characteristics

The final study population consisted of 51 participants; 28 women (mean age, 69.7 years; range, 34-84 years) and 23 men (mean age 66.6 years; range, 38-85 years). Most participants had benign pancreatic disease.

Participant flow

Of the 474 individuals who underwent MRCP with four MR systems in Kindai University Hospital between July and October 2018, consecutive 58 individuals undergoing MRCP with an MRI system available for CS were recruited for this study. Among them, one refused to participate. The other 57 participants were planned for three MRCP sequences including NT SENSE, NT C-SENSE, and BH C-SENSE. Six participants were excluded because they were disqualified according to the exclusion criteria. One dropped out after beginning the examination; two had no imaging data (the both were unable to hold their breath because of abdominal pain); three had liver lesions disrupted evaluation of hilar bile ducts (all had multiple liver cysts). The final study population consisted of 51 participants.

Adverse events

None

Outcome measures

1. We compared the three types of MRCP images using the signal intensities and the relative duct-to-periductal contrast ratios (RC values) of bile duct segments including the right intrahepatic bile duct (RHD), left intrahepatic bile duct (LHD), and common bile duct (CBD)using the relative duct-to-periductal contrast ratios.
2. The readers graded the visualization of the intrahepatic duct, common hepatic duct, cystic duct, CBD, and main pancreatic duct on a 5-point Likert scale.
3. The rates of participants with available images were compared among three MRCP methods according to individual-related factors including age, sex, history of chest or abdominal surgery, presence of pleural effusion or ascites, chest or cardiac comorbidities, poor physical condition on the day of MR acquisition, and factors possibly related to lack of communication (hearing impairment, anxiety state, or intellectual disability) in the context of whether the participant could follow the breathing instructions.

Plan to share IPD

IPD sharing Plan description

Progress

Recruitment status

Completed

Date of protocol fixation

2018 Year 07 Month 10 Day

Date of IRB

2018 Year 07 Month 13 Day

Anticipated trial start date

2018 Year 07 Month 19 Day

Last follow-up date

2018 Year 08 Month 01 Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other

Other related information

We will assess image quality of 3D navigator-triggered MRCP with combined parallel imaging and compressed sensing reconstruction at 1.5T MR scanner.

Management information

Registered date

2018 Year 07 Month 17 Day

Last modified on

2020 Year 01 Month 16 Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038097

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name