UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051430 |
|---|---|
| Receipt number | R000058667 |
| Scientific Title | Observational study to elucidate the pathogenesis of portal hypertension in diffuse liver disease using perfusion CT |
| Date of disclosure of the study information | 2023/06/23 |
| Last modified on | 2023/06/23 15:49:23 |
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Basic information
Public title
Observational study to elucidate the pathogenesis of portal hypertension in diffuse liver disease using perfusion CT
Acronym
Observational study to elucidate the pathogenesis of portal hypertension in diffuse liver disease using perfusion CT
Scientific Title
Observational study to elucidate the pathogenesis of portal hypertension in diffuse liver disease using perfusion CT
Scientific Title:Acronym
Observational study to elucidate the pathogenesis of portal hypertension in diffuse liver disease using perfusion CT
Region
| Japan |
Condition
Condition
diffuse liver disease
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Perfusion CT is performed before and after treatment involving alteration of portal blood flow in patients with diffuse liver disease. Evaluate changes in portal vein blood flow and arterial blood flow before and after treatment, and seek to elucidate the pathology. In addition, we will elucidate the characteristics of blood flow distribution in non-cirrhotic liver diseases such as idiopathic portal hypertension (IPH), Budd-Chiari syndrome, and extrahepatic portal vein occlusion (EHO).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation of changes in portal vein perfusion and arterial perfusion by perfusion CT
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients with diffuse liver disease
2) Patients with pathological conditions associated with portal hypertension and scheduled perfusion CT examination in routine practice for evaluation of treatment involving alteration of portal blood flow
3) Patients aged 20 years or older at the time of informed consent
4) Patients who have given written informed consent of their own free will after receiving sufficient explanation about participating in this study.
Key exclusion criteria
1) Patients who are examined in routine clinical practice and who are judged by the principal investigator or sub-investigator to be inappropriate for conducting this study safely
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Naoya |
| Middle name | |
| Last name | Kato |
Organization
Chiba University Hospital
Division name
Gastroenterology
Zip code
2608677
Address
1-8-1 Chuo Ward, Chiba City, Chiba Prefecture
TEL
043222717
kato.naoya@chiba-u.jp
Public contact
Name of contact person
| 1st name | Takayuki |
| Middle name | |
| Last name | Kondo |
Organization
Chiba University Hospital
Division name
Gastroenterology
Zip code
2608677
Address
1-8-1 Chuo Ward, Chiba City, Chiba Prefecture
TEL
0432227171
Homepage URL
takakon@chiba-u.jp
Sponsor or person
Institute
Chiba University
Institute
Department
Personal name
Funding Source
Organization
Chiba University
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
Chiba University Hospital
Address
1-8-1 Chuo Ward, Chiba City, Chiba Prefecture
Tel
0432227171
fujimoto.kentarou@chiba-u.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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 06 | Month | 23 | 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 | 04 | Month | 27 | Day |
Date of IRB
| 2023 | Year | 04 | Month | 27 | Day |
Anticipated trial start date
| 2023 | Year | 04 | Month | 27 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Perfusion CT is performed before and after treatment involving alteration of portal blood flow in patients with diffuse liver disease. Evaluate changes in portal vein blood flow and arterial blood flow before and after treatment, and seek to elucidate the pathology. In addition, we will elucidate the characteristics of blood flow distribution in non-cirrhotic liver diseases such as idiopathic portal hypertension (IPH), Budd-Chiari syndrome, and extrahepatic portal vein occlusion (EHO).
Management information
Registered date
| 2023 | Year | 06 | Month | 23 | Day |
Last modified on
| 2023 | Year | 06 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058667
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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