UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062018 |
|---|---|
| Receipt number | R000070966 |
| Scientific Title | Registry Study of Clinical Outcomes in Patients with Steatotic Liver Disease Undergoing Liver Stiffness Measurement |
| Date of disclosure of the study information | 2026/06/23 |
| Last modified on | 2026/06/23 09:23:16 |
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Basic information
Public title
Asian Vibration-Controlled Transient Elastography registry study
Acronym
AVENGERS
Scientific Title
Registry Study of Clinical Outcomes in Patients with Steatotic Liver Disease Undergoing Liver Stiffness Measurement
Scientific Title:Acronym
AVENGERS
Region
| Japan |
Condition
Condition
Nonalcoholic fatty liver disease (NAFLD), which is now known as metabolic dysfunction-associated steatotic liver disease (MASLD).
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study was designed to clarify the impact of comorbidities and their corresponding medications on overall prognosis in patients with steatotic liver disease who underwent liver stiffness measurement, using data from a multicenter registry.
Basic objectives2
Others
Basic objectives -Others
Cardiovascular events, including stroke
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Whether higher liver stiffness measurement (LSM) values are associated with increased all-cause mortality.
Key secondary outcomes
1.Extrahepatic comorbidities
2.Liver-related events
3.Whether patient-related factors are associated with the development of extrahepatic malignancies
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 suspected of having steatotic liver disease who underwent their first liver stiffness measurement (FibroScan) on or after January 1, 2012.
2. Age >=20 years at the time of the initial liver stiffness measurement (enrollment).
Key exclusion criteria
1. Patients deemed unsuitable for participation in this study by the investigator.
2. Patients who declined participation in the study.
3. Patients suspected of having concomitant chronic liver diseases other than steatotic liver disease.
Target sample size
6000
Research contact person
Name of lead principal investigator
| 1st name | Hidenori |
| Middle name | |
| Last name | Toyoda |
Organization
Ogaki Municipal Hospital
Division name
Department of Gastroenterology and Hepatology,
Zip code
503-8502
Address
4-86 Minaminokawa-cho, Ogaki City, Gifu
TEL
0584-81-3341
hmtoyoda@spice.ocn.ne.jp
Public contact
Name of contact person
| 1st name | Hideki |
| Middle name | |
| Last name | Fujii |
Organization
Osaka Metropolitan University
Division name
Department of Nutrition Graduate School of Human Life and Ecology
Zip code
536-8525
Address
2-1-132, Morinomiya, Joto-ku, Osaka-shi, Osaka 536-8525, JAPAN
TEL
06-6167-1369
Homepage URL
o21717h@omu.ac.jp
Sponsor or person
Institute
JSG-NAFLD
Institute
Department
Personal name
Funding Source
Organization
JSG-NAFLD
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
Institutional Review Board (IRB) of Ogaki Municipal Hospital
Address
2-1-132, Morinomiya, Joto-ku, Osaka-shi, Osaka 536-8525, JAPAN
Tel
0584-81-3341
clinical-trial@omh.ogaki.gifu.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 | 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
5200
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
No longer recruiting
Date of protocol fixation
| 2023 | Year | 02 | Month | 02 | Day |
Date of IRB
| 2023 | Year | 03 | Month | 24 | Day |
Anticipated trial start date
| 2023 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Liver biopsy is an invasive procedure associated with risks such as bleeding and is also a costly diagnostic test. If accurate prognostic prediction of MASLD can be achieved using noninvasive assessment methods it may become possible to reduce or even eliminate the need for liver biopsy in routine clinical practice. Such an advance is expected not only to improve patients quality of life but also to reduce healthcare costs and ultimately contribute to extending healthy life expectancy.
Management information
Registered date
| 2026 | Year | 06 | Month | 23 | Day |
Last modified on
| 2026 | 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=R000070966
