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This study aims to evaluate the diagnostic utility of ultrasound-derived fat fraction (UDFF) in assessing hepatic steatosis in patients with suspected metabolic dysfunction-associated steatotic liver disease (MASLD). Using a prospective, cross-sectional design, the study will compare UDFF results with established diagnostic methods, including liver biopsy, MRI proton density fat fraction (PDFF), and controlled attenuation parameters (CAP) measurements. The ultimate goal is to determine if UDFF can serve as a non-invasive alternative to liver biopsy for diagnosing and staging hepatic steatosis, potentially reducing the need for invasive procedures in MASLD management.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| UDFF | Diagnostic Test | Ultrasound-Derived Fat Fraction (UDFF) is a quantitative ultrasound technique used to assess hepatic steatosis by measuring the amount of fat in the liver tissue. UDFF estimates fat content using specific ultrasound parameters, namely the attenuation coefficient (AC) and backscatter coefficient (BSC). The AC measures the rate at which ultrasound waves weaken as they pass through the liver, which correlates with fat content, while the BSC quantifies the amount of reflected ultrasound signal, providing additional insights into liver tissue characteristics. |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation and agreement between UDFF and PDFF | Spearman rank correlation coefficient Intraclass correlation coefficient (ICC) with a 2-way random effects model for absolute agreement Bland-Altman plots | During procedure |
| Diagnostic performance of UDFF for detecting and grading steatosis based on PDFF and histologic reference | AUROC analysis | During procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Intra-observer and inter-observer agreement | Intraclass correlation coefficient | During procedure |
| UDFF performance in different fibrosis stages | Subgroup analysis according to different fibrosis stages |
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Inclusion Criteria:
Exclusion Criteria:
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Patients suspected of MASLD, who are scheduled for pathologic exam such as liver biopsy or surgery
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asan Medical Center | Seoul | Songpa-gu | 05505 | South Korea |
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| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D005355 | Fibrosis |
| ID | Term |
|---|---|
| D004066 | Digestive System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Pathological degree of hepatic steatosis and fibrosis
| During procedure |