UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060020 |
|---|---|
| Receipt number | R000068646 |
| Scientific Title | Reproducibility and clinical validity of liver stiffness measurement using EUS-guided shear-wave elastography in patients with steatotic liver disease: an analysis using Baveno VII stratification |
| Date of disclosure of the study information | 2025/12/09 |
| Last modified on | 2025/12/09 06:22:05 |
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Basic information
Public title
Reproducibility of liver stiffness measurement using EUS-SWE and its association with a simple platelet count and AST/ALT ratio-based risk stratification in steatotic liver disease: a prospective observational study
Acronym
HITO-EUS-SWE
Scientific Title
Reproducibility and clinical validity of liver stiffness measurement using EUS-guided shear-wave elastography in patients with steatotic liver disease: an analysis using Baveno VII stratification
Scientific Title:Acronym
HITO-EUS-SWE-SLD
Region
| Japan |
Condition
Condition
steatotic liver disease (SLD)
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the reproducibility (primary) and clinical validity (secondary) of liver stiffness (kPa) measured by EUS-SWE in patients with steatotic liver disease (SLD), including MASLD/MetALD/ALD. Clinical validity will be assessed by its association with a Baveno VII-referenced alternative stratification based on platelet count (PLT) and the AST/ALT ratio (AAR) (PLT-AAR).
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
intra-operator reproducibility assessed using ICC and Bland-Altman analysis (mean difference and 95% limits of agreement)
Key secondary outcomes
Clinical validity assessed by AUROC for PLT-AAR stratification with sensitivity, specificity, and optimal thresholds; correlations with PLT, AAR, FIB-4; and feasibility/quality metrics including IQR/median, success rate, procedure time, and complications.
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
Inclusion criteria: (1) Adults aged 20 years and older clinically diagnosed with SLD (MASLD/MetALD/ALD) scheduled to undergo EUS as part of routine care; (2) ability to provide written informed consent.
Key exclusion criteria
Exclusion criteria: conditions judged unsuitable for EUS (e.g., severe general condition, high bleeding risk), pregnancy or suspected pregnancy, comorbidities or cognitive impairment interfering with participation, or any other reason deemed inappropriate by the principal investigator.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Takako |
| Middle name | |
| Last name | Nomura |
Organization
HITO Medical Center
Division name
Department of Gastroenterology and Hepatology
Zip code
7990121
Address
788-1, Kamibun-Cho, Shikokutyuou-city, Ehime, Japan
TEL
0896582222
nomura.takako@hito-medical.net
Public contact
Name of contact person
| 1st name | Takako |
| Middle name | |
| Last name | Nomura |
Organization
HITO Medical Center
Division name
Department of Gastroenterology and Hepatology
Zip code
7990121
Address
788-1, Kamibun-Cho, Shikokutyuou-city, Ehime, Japan
TEL
0896582222
Homepage URL
nomura.takako@hito-medical.net
Sponsor or person
Institute
HITO Medical Center
Institute
Department
Personal name
Funding Source
Organization
HITO Medical Center
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
HITO Medical Center
Address
788-1, Kamibun-Cho, Shikokutyuou-city, Ehime, Japan
Tel
0896582222
nomura.takako@hito-medical.net
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
| 2025 | Year | 12 | Month | 09 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 12 | Month | 09 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a prospective non-interventional observational study in which EUS-SWE liver stiffness measurements will be additionally obtained within clinically indicated EUS and analyzed. No new treatment or drug administration is involved. The main study-related burden is an approximately 3-minute extension of the examination time. Data will be managed using linkable anonymization. The study is funded by departmental research funds without industry funding or device provision. The study outline will be registered and publicly available in UMIN-CTR.
Management information
Registered date
| 2025 | Year | 12 | Month | 09 | Day |
Last modified on
| 2025 | Year | 12 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068646
