UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052852 |
|---|---|
| Receipt number | R000060314 |
| Scientific Title | Validation of unification of splenic hardness measurement to elucidate the pathogenesis of portal hypertension |
| Date of disclosure of the study information | 2023/11/21 |
| Last modified on | 2024/06/24 06:09:37 |
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Basic information
Public title
Validation of unification of splenic hardness measurement to elucidate the pathogenesis of portal hypertension
Acronym
Validation of unification of splenic hardness measurement to elucidate the pathogenesis of portal hypertension
Scientific Title
Validation of unification of splenic hardness measurement to elucidate the pathogenesis of portal hypertension
Scientific Title:Acronym
Validation of unification of splenic hardness measurement to elucidate the pathogenesis of portal hypertension
Region
| Japan |
Condition
Condition
diffuse liver disease
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Liver fibrosis is thought to be involved in the pathogenesis of portal hypertension, and liver hardness has conventionally been measured by abdominal ultrasonography. On the other hand, there is no established method for measuring splenic hardness, and the relationship between splenic hardness and liver hardness has not been fully verified. Therefore, we will measure splenic hardness in patients with diffuse liver disease to verify its usefulness and to establish a measurement method.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Correlation between splenic hardness and hepatic venous pressure gradient (HVPG)
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
| 15 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who meet all of the following conditions are eligible
1) Patients with diffuse liver disease
(2) Patients who are 15 years of age or older at the time of consent
(3) Patients who have been fully informed of the study and who have given their voluntary written consent based on their full understanding of the study.
4) For minors under 18 years of age, patients who have obtained written consent from a surrogate.
Key exclusion criteria
Patients who meet any of the following conditions will not be included in the study
1) Patients who are tested in the usual course of medical care and who are deemed by the investigator or subinvestigator to be unsuitable for the safe conduct of this study.
Target sample size
200
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
2648677
Address
1-8-1 Chuo Ward, Chiba City, Chiba Prefecture
TEL
43222717
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
43222717
Homepage URL
takakon@chiba-u.jp
Sponsor or person
Institute
Chiba University
Institute
Department
Personal name
Funding Source
Organization
Nothing
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
43222717
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 | 11 | Month | 21 | 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 | 10 | Month | 12 | Day |
Date of IRB
| 2023 | Year | 10 | Month | 12 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 12 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Liver hardness and spleen hardness were measured by abdominal ultrasonography in patients with diffuse liver disease. By comparing the results with those of other examinations conducted in the usual medical care, we will establish a method of measuring spleen hardness that best reflects fibrosis and inflammation of the liver, and seek its application in differentiating and diagnosing diffuse liver disease.
Management information
Registered date
| 2023 | Year | 11 | Month | 21 | Day |
Last modified on
| 2024 | Year | 06 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060314
