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

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 - HITO-EUS-SWE-SLD

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000060020

Enrollment

100

Registered

2025-12-09

Start date

2025-12-09

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

steatotic liver disease (SLD)

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

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.

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
intra-operator reproducibility assessed using ICC and Bland-Altman analysis (mean difference and 95% limits of agreement)	—

Secondary

Measure	Time frame
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.	—

Countries

Japan

Contacts

Public ContactTakako Nomura

HITO Medical Center Department of Gastroenterology and Hepatology

nomura.takako@hito-medical.net0896582222

Outcome results