UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050870 |
|---|---|
| Receipt number | R000057974 |
| Scientific Title | Hemodynamic study of the portal venous region using 3D cine phase contrast MRI (4D Flow MRI) |
| Date of disclosure of the study information | 2023/05/15 |
| Last modified on | 2024/04/17 16:43:13 |
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Basic information
Public title
Hemodynamic study of the portal venous region using 3D cine phase contrast MRI (4D Flow MRI)
Acronym
Hemodynamic study of the portal venous region using 3D cine phase contrast MRI (4D Flow MRI)
Scientific Title
Hemodynamic study of the portal venous region using 3D cine phase contrast MRI (4D Flow MRI)
Scientific Title:Acronym
Hemodynamic study of the portal venous region using 3D cine phase contrast MRI (4D Flow MRI)
Region
| Japan |
Condition
Condition
abnormal portal venous hemodynamics
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We will objectively and quantitatively show how the degree of hepatic injury or transcatheter or surgical intervention in the portal venous region affects portal vein blood flow using blood flow parameters derived from 4D Flow MRI, and clarify the relationship between portal venous blood flow and hepatic regeneration, portal vein thrombus, and treatment efficacy. We will also clarify whether predicting the degree of liver regeneration, the appearance of portal vein thrombi, and the efficacy of interventional and surgical treatment in advance is possible.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
For liver transplant donors and recipients, liver volume increase at 3 months postoperatively (increased portal venous blood flow/wall shear stress postoperatively as an exposure/predictor); for cases of portal vein thrombus (RRT value of the main trunk of the portal vein as an exposure/predictor); and for hepatic encephalopathy, improvement of hepatic encephalopathy after transcatheter portal collateral embolization (increased liver blood flow and changes in blood flow from the superior mesenteric vein into the portal vein due to portosystemic shunt embolization as exposure/predictor) will be evaluated.
Key secondary outcomes
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
| 18 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients requiring evaluation of blood flow in the portal venous region. Specifically, patients with hepatic dysfunction or patients who require evaluation before and after treatment.
Adult patients who understand the study and have given written consent.
Key exclusion criteria
Patients who have difficulty with MRI imaging, such as claustrophobia or implantation of non-MRI compatible metal devices.
For contrast studies, patients with contrast allergy or renal insufficiency.
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | Ryota |
| Middle name | |
| Last name | Hyodo |
Organization
Nagoya University Hospital
Division name
Radiology
Zip code
4668560
Address
65, Tsurumai-tyo, Showa-Ku, Nagoya-city, Aichi-ken
TEL
0527442327
ryouta771@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Ryota |
| Middle name | |
| Last name | Hyodo |
Organization
Nagoya University Hospital
Division name
Radiology
Zip code
4668560
Address
65, Tsurumai-tyo, Showa-Ku, Nagoya-city, Aichi-ken
TEL
0527442327
Homepage URL
ryouta771@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University
Institute
Department
Personal name
Ryota Hyodo
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagoya University Hospital
Address
65, Tsurumai-tyo, Showa-Ku, Nagoya-city, Aichi-ken
Tel
0527442423
ethics@med.nagoya-u.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
名古屋大学医学部附属病院（愛知県）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 05 | Month | 15 | 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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 05 | Month | 30 | Day |
Date of IRB
| 2023 | Year | 07 | Month | 06 | Day |
Anticipated trial start date
| 2023 | Year | 07 | Month | 06 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2023 | Year | 04 | Month | 17 | Day |
Last modified on
| 2024 | Year | 04 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057974
