Usefulness of Ultrasound-derived Fat Fraction for Quantification of Hepatic Steatosis in Patients Suspected of MASLD

This prospective observational study, conducted at a single tertiary institution, will investigate the efficacy of ultrasound-derived fat fraction (UDFF) and point shear wave elastography (p-SWE) as non-invasive methods for quantifying liver fat content and fibrosis in patients scheduled for liver biopsy or surgery. The study will enroll 150 participants, suspected of MASLD and who are candidates for liver biopsy or resection.

The study will utilize Siemens ultrasound equipment to measure the UDFF using attenuation coefficient (AC) and backscatter coefficient (BSC) values for liver fat quantification. Additionally, TE parameters, such as controlled attenuation parameter (CAP) and liver stiffness measurement (LSM), will be recorded for comparison. The primary outcomes will assess UDFF's diagnostic accuracy against liver biopsy and MRI-PDFF. Secondary outcomes will include assessment of intra- and inter-observer variability, and correlations with patients' clinical data, such as BMI, liver fibrosis stages and liver function tests.

Expected benefits include validating UDFF as a reliable, non-invasive alternative for liver fat assessment, potentially reducing the need for invasive biopsies in managing liver disease.

Inclusion criteria

• Patients older than 18 and younger than 80 years
• Patients suspected of MASLD
• Patients who are planned to undergo either liver biopsy or surgery
• Patients willing to provide written informed consent.

Exclusion criteria

• Patients with a large tumor in Rt. hemiliver causing difficulty in performing UDFF measurement
• Patients with previous liver surgery or transplantation
• Patients with insufficient pathologic specimen for analysis of steatosis and fibrosis grade.
• Any other condition which, in the opinion of the investigator, would make the patient unsuitable for enrollment or could interfere with completing the study.