UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060333 |
|---|---|
| Receipt number | R000062315 |
| Scientific Title | EUS-AI for steatohepatitis |
| Date of disclosure of the study information | 2026/01/14 |
| Last modified on | 2026/01/13 09:00:04 |
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Basic information
Public title
Utility of EUS attenuation imaging for diagnosis and severity of steatohepatitis: a multicenter prospective study
Acronym
EUS-AI for steatohepatitis
Scientific Title
EUS-AI for steatohepatitis
Scientific Title:Acronym
EUS-AI for steatohepatitis
Region
| Japan |
Condition
Condition
steatohepatitis
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We evaluate the utility of EUS-AI for the diagnosis of steatohepatitis in clinical practice.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The sensitivity, specificity, and accuracy with EUS-AI for steatohepatitis diagnosed by CT and the correlation between value with EUS-AI and CT value for liver.
Key secondary outcomes
1.The comparison of EUS-AI and conventional abdominal ultrasound AI for diagnosis according to steatohepatitis diagnosed by CT.
2.The comparison of EUS-AI and MRI for diagnosis according to steatohepatitis diagnosed by CT.
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
1. Patients over 18 years old
2. Patients scheduled for EUS and CT
Key exclusion criteria
1. Cases in which EUS is difficult to perform
2. Patients who are judged to be ineligible for this study by the investigator
3. Patients with psychiatric disorders
Target sample size
600
Research contact person
Name of lead principal investigator
| 1st name | Masayuki |
| Middle name | |
| Last name | Kitano |
Organization
Wakayama medical university
Division name
Second Department of Internal Medicine
Zip code
6410012
Address
811-1, Kimiidera, Wakayama City, Wakayama
TEL
0734472300
kitano@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | Yasunobu |
| Middle name | |
| Last name | Yamashita |
Organization
Wakayama Medical University
Division name
Second Department of Internal Medicine
Zip code
6410012
Address
811-1, Kimiidera, Wakayama City, Wakayama
TEL
0734472300
Homepage URL
yasunobu@wakayama-med.ac.jp
Sponsor or person
Institute
Wakayama medical university
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Wakayama Medical University Hospital
Address
811-1, Kimiidera, Wakayama City, Wakayama
Tel
0734410897
wa-rinri@wakayama-med.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
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 01 | Month | 14 | 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
529
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
Completed
Date of protocol fixation
| 2024 | Year | 02 | Month | 29 | Day |
Date of IRB
| 2024 | Year | 04 | Month | 02 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 09 | 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
Prospective, Multicenter Cohort Study
Management information
Registered date
| 2026 | Year | 01 | Month | 13 | Day |
Last modified on
| 2026 | Year | 01 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062315
