UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062754 |
|---|---|
| Receipt number | R000071850 |
| Scientific Title | A Prospective Observational Study of Histopathological Validation of Liver Stiffness Measurement Using Endoscopic Ultrasound Shear Wave Elastography (EUS-SWE) in Steatotic Liver Disease: Comparison with Fibrosis Assessment by EUS-Guided Liver Biopsy |
| Date of disclosure of the study information | 2026/08/31 |
| Last modified on | 2026/08/31 19:37:10 |
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Basic information
Public title
A Study Comparing Liver Stiffness Measured Using Endoscopic Ultrasound with Liver Biopsy Findings in Patients with Steatotic Liver Disease
Acronym
A Study Comparing Liver Stiffness and Liver Tissue in Steatotic Liver Disease
Scientific Title
A Prospective Observational Study of Histopathological Validation of Liver Stiffness Measurement Using Endoscopic Ultrasound Shear Wave Elastography (EUS-SWE) in Steatotic Liver Disease: Comparison with Fibrosis Assessment by EUS-Guided Liver Biopsy
Scientific Title:Acronym
EUS-SWE Histopathological Validation Study in Steatotic Liver Disease
Region
| Japan |
Condition
Condition
Steatotic Liver Disease
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the association between liver stiffness measured by EUS-SWE and the degree of histological liver fibrosis assessed using liver biopsy specimens processed and diagnosed as part of routine clinical care.
Basic objectives2
Others
Basic objectives -Others
Evaluation of the histopathological validity of liver stiffness measurement using EUS-SWE
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Association between liver stiffness measured by EUS-SWE and the degree of histological liver fibrosis assessed using liver biopsy specimens processed and diagnosed as part of routine clinical care.
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 aged 20 years or older.
2. Patients with steatotic liver disease (SLD) who have been found to have hepatic steatosis on liver imaging, such as abdominal ultrasonography, computed tomography (CT), or magnetic resonance imaging (MRI).
3. Patients scheduled to undergo upper gastrointestinal endoscopic ultrasonography (EUS) as part of routine clinical care.
4. Patients considered able to undergo attempted liver stiffness measurement using EUS-SWE.
5. Patients who have received an explanation of the study objectives and procedures and are able to provide written informed consent to participate.
Key exclusion criteria
1. Patients in whom EUS is considered inappropriate.
2. Patients in whom a safe needle trajectory cannot be secured when EUS-guided liver biopsy is to be performed.
3. Patients considered to be at high risk of bleeding.
4. Patients for whom interruption or management of antithrombotic therapy is difficult and EUS-guided liver biopsy is therefore considered inappropriate.
5. Patients with a severely impaired general condition.
6. Patients who are pregnant or highly likely to be pregnant.
7. Patients with comorbidities or cognitive impairment that would interfere with participation in the study.
8. Patients otherwise deemed unsuitable for participation by the principal investigator or a study investigator.
Target sample size
120
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 & Hepatology
Zip code
7990121
Address
788-1 Kamibun-Cho, Shikokuchuo City, Ehime 799-0121, Japan
TEL
0896-58-2222
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 & Hepatology
Zip code
7990121
Address
788-1 Kamibun-Cho, Shikokuchuo City, Ehime 799-0121, Japan
TEL
0896-58-2222
Homepage URL
nomura.takako@hito-medical.net
Sponsor or person
Institute
HITO Medical Center
Institute
Department
Personal name
Funding Source
Organization
None
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
HITO Medical Center
Address
788-1 Kamibun-Cho, Shikokuchuo City, Ehime 799-0121, Japan
Tel
0896-58-2222
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
| 2026 | Year | 08 | Month | 31 | 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
Enrolling by invitation
Date of protocol fixation
| 2026 | Year | 07 | Month | 26 | Day |
Date of IRB
| 2026 | Year | 08 | Month | 13 | Day |
Anticipated trial start date
| 2026 | Year | 08 | Month | 13 | 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 multicenter prospective observational study of patients with suspected steatotic liver disease (SLD) who undergo upper gastrointestinal endoscopic ultrasonography (EUS) as part of routine clinical care. Liver stiffness will be measured using EUS-SWE during routine EUS, and the feasibility, measurement quality, and within-session repeatability will be evaluated. Among patients for whom EUS-guided liver biopsy is clinically indicated, the association between liver stiffness and the degree of histological liver fibrosis assessed using liver biopsy specimens will be investigated. EUS B-mode images, MRI-proton density fat fraction (MRI-PDFF), and clinical data obtained during routine clinical care will also be collected for exploratory assessment of hepatic steatosis. Eligible patients who provide written informed consent will be prospectively enrolled. No EUS-guided liver biopsy, additional needle puncture, MRI, or other examination will be performed solely for research purposes, and no research-specific intervention or allocation will be conducted.
Management information
Registered date
| 2026 | Year | 08 | Month | 31 | Day |
Last modified on
| 2026 | Year | 08 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071850
