臨床研究等提出・公開システム

Date of registration	Aug. 24, 2026
Last modified on	Aug. 24, 2026
Trial ID	jRCT1030260421

Scientific Title	Clinical and Fibro-Inflammatory Characteristics Across Steatotic Liver Disease Categories Assessed by Transient Elastography in a Community-Based Outpatient Cohort [None]
Public Title	Study on the clinical course of steatotic liver disease using transient elastography [None]

Contact for Scientific Queries	Name	Hirono Shuichi
	Affiliation	Department of Internal Medicine, Hirono Naika Clinic
	Address	3582-1 Hongo Kitakata, Miyazaki-shi, Miyazaki
	Telephone	+81-985-52-7311
	E-mail	hironos3582@hirono-naika.jp
Contact for Public Queries	Name	hirono shuichi
	Affiliation	Department of Internal Medicine, Hirono Naika Clinic
	Address	3582-1 Hongo Kitakata, Miyazaki-shi, Miyazaki
	Telephone	+81-985-52-7311
	E-mail	hironos3582@hirono-naika.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		May. 01, 2023
Target sample size		380
Study Type		Observational
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	uncontrolled control
	assignment	single assignment
	purpose	diagnostic purpose
Key inclusion & exclusion criteria	Inclusion Criteria	1. Outpatients managed in a community-based general practice at our clinic.2. Patients with steatotic liver disease (SLD) who have undergone or are scheduled to undergo transient elastography (FibroScan).3. Patients who did not opt out of the study regarding the use of their clinical data.
	Exclusion Criteria	1. Patients with critical missing clinical or laboratory data precluding appropriate statistical analysis.2. Patients otherwise judged by the principal investigator to be unsuitable for the study.
	Age Minimum	No limit
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Steatotic Liver Disease
Health Condition(s) Keyword		Steatotic liver disease, Fatty liver, Liver fibrosis, Transient elastography, Cohort study
Primary Outcome(s)		Longitudinal changes in the FAST score, Agile3+, and Agile4 scores over time (until the end of 2028) assessed via transient elastography (FibroScan) across different steatotic liver disease (SLD) categories, including MASLD, MetALD, and ALD.
Secondary Outcome(s)		1. Longitudinal changes in individual liver stiffness measurement (LSM) and controlled attenuation parameter (CAP) values obtained by transient elastography.2. Serial changes in blood test parameters (AST, ALT, platelet count, etc.) and clinical characteristics (age, sex, presence of glucose intolerance, etc.).3. Comparison of hepatic fibrosis and inflammatory characteristics among different SLD categories.

Primary Sponsor	Hirono Naika Clinic

Name of Certified Review Board	Ethics Committee of Japan Association of Clinics and Physicians
Address	4F Minamoto Kitchoan Bldg., 3-28-5 Kanda Ogawamachi, Chiyoda-ku, Tokyo, Tokyo
Telephone	+81-3-3259-6011
E-Mail	irb@nichirinnai.jp
Approval Status	Approval
Date of approval	June. 02, 2026

Plan to share IPD	No

Countries of Recruitment（Except Japan）	None