UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000033423
Receipt No. 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 (Ver. 7)

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

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 50

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
Institute Kindai University Faculty of Medicine
Institute
Department

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
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 51
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038097