| 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) |
| 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 | |
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| Condition | |||
| Condition | pancreato-biliary diseases | ||
| Classification by specialty |
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| 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 | |
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| Purpose of intervention | |
| Type of intervention | |
| Interventions/Control_1 | |
| Interventions/Control_2 | |
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| Interventions/Control_6 | |
| Interventions/Control_7 | |
| Interventions/Control_8 | |
| Interventions/Control_9 | |
| Interventions/Control_10 | |
| Eligibility | ||||
| Age-lower limit |
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| Age-upper limit |
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| 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 |
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| 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 |
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| Target sample size | 50 | |||
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| Name of lead principal investigator |
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| 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 | ||||||
| thyodo@med.kindai.ac.jp | |||||||
| Public contact | |||||||
| Name of contact person |
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| 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 | ||||||
| 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) |
| 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 |
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| 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. |
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| Results date posted |
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| Results Delayed | |||||||
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| Date of the first journal publication of results |
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| 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. |
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| 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. |
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| Adverse events | None |
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| 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. |
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| Plan to share IPD | |||||||
| IPD sharing Plan description | |||||||
| Progress | |||||||
| Recruitment status | Completed | ||||||
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| 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. |
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| Registered date |
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| Link to view the page | |
| URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038097 |