Samsung S-Viscosity vs Canon Dispersion Slope in Steatotic Liver Disease (SAVID-SLD)

ConditionsMetabolic Dysfunction-Associated Steatotic Liver Disease Fatty Liver Liver Fibrosis

Trial statusActive, not recruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18+

SponsorSeoul National University Hospital

About this trial

Steatotic liver disease (SLD) is one of the most common chronic liver diseases worldwide. Distinguishing simple steatosis from metabolic dysfunction-associated steatohepatitis (MASH) with significant fibrosis is clinically important, but liver biopsy - the current standard - is invasive. Recent ultrasound technology allows noninvasive measurement of tissue viscoelasticity, which has been linked to liver inflammation. Samsung Medison's R20 system (S-Viscosity) and Canon Aplio i800 (Dispersion Slope Imaging) both provide vendor-specific viscoelasticity parameters derived from shear-wave dispersion analysis, but their relationship and agreement have not been compared in SLD patients.

This prospective single-center observational study will enroll approximately 95-100 participants in three cohorts: (A) 15-20 living-donor candidates as a healthy reference, (B+C) approximately 80 adults with sonographically suspected or confirmed SLD recruited consecutively. SLD participants will be classified post-hoc into low-MASH-risk (Cohort B) and at-risk MASH (Cohort C) subgroups using a multi-parametric stratification combining liver stiffness (LSM), DeepUSFF (deep-learning-based ultrasound fat fraction), and serum AST. All participants will undergo same-day ultrasound examination with both Samsung HERA W12 and Canon Aplio i800. The primary objective is to evaluate the correlation and agreement between Samsung S-Viscosity and Canon Dispersion Slope. Secondary objectives include deriving a normal reference range from the healthy cohort, comparing viscoelasticity parameters across cohorts, and exploring a Modified US-FAST score.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

[Cohort A - Healthy reference]

Adults ≥18 years old

Currently undergoing living-donor evaluation at SNUH

Donor evaluation confirms (a) hepatic steatosis <5% by imaging or biopsy, (b) normal AST/ALT, and (c) absence of chronic liver disease (HBV, HCV, autoimmune, cholestatic, etc.)

Disqualifiers

• Significant alcohol intake within the past 2 years (>30-60 g/day for males, >20-50 g/day for females)

Diagnosed or strongly suspected chronic liver disease (active HBV/HCV, autoimmune liver disease, cholestatic liver disease, Wilson's disease, hemochromatosis, etc.)

Suspected hepatic failure or decompensated cirrhosis (albumin <3.2 g/dL, INR >1.3, direct bilirubin >1.3 mg/dL)

Ascites, history of variceal bleeding, or acute biliary obstruction rendering stable measurements unfeasible

Trial population

Adults aged 18 years or older recruited from Seoul National University Hospital, including (1) living-donor candidates undergoing donor evaluation as a healthy reference cohort, and (2) outpatients with sonographically suspected or confirmed hepatic steatosis scheduled for clinical abdominal ultrasound.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Samsung Medison HERA W12 (R30) with S-Shearwave platform
Device
Two-dimensional shear-wave elastography acquisition with the Samsung HERA W12 R30 system using the CA 1-7S convex probe. Five valid measurements per parameter are obtained from the right hepatic lobe via right intercostal approach, repeated in 2 sessions. Output parameters include S-Viscosity (dispersion-derived viscosity index), 2D S-SWE (liver stiffness in kPa), TAI (tissue attenuation imaging), and DeepUSFF (deep-learning-based ultrasound fat fraction in %).
Canon Aplio i800 with Dispersion Slope Imaging
Device
Two-dimensional shear-wave elastography and Dispersion Slope Imaging acquisition with the Canon Aplio i800 system using the i8C1 convex probe. Five valid measurements are obtained from the right hepatic lobe via right intercostal approach. Output parameters include 2D SWE (liver stiffness in kPa) and Dispersion Slope (in \[m/s\]/kHz, viscosity-related).

Treatment groups

95 Participants

are divided into 4 treatment groups

Group A: Cohort A: Healthy Reference (Living-donor candidates)2 interventions

Group B: Cohort B: Low MASH Risk MASLD (Rule-out)2 interventions

Group C: Cohort C: At-Risk MASH MASLD (Rule-in)2 interventions

Group D: Cohort D: Indeterminate Zone (Exploratory subgroup)2 interventions

Trial outcomes

Primary outcomes

Correlation between Samsung S-Viscosity and Canon Dispersion Slope

Pearson or Spearman correlation coefficient (with 95% CI) between Samsung S-Viscosity and Canon Dispersion Slope, calculated from the median of 5 valid measurements per device per participant.

Time frame