EUS-Guided ATI and SWE in Individuals With Normal FibroScan

Condition(s) studied

Investigational drug(s) / intervention(s)

Endoscopic Ultrasound (EUS): A clinically indicated diagnostic endoscopic ultrasound will be performed according to standard institutional practice. During the examination, the liver will be visualized from the stomach and duodenum to allow quantitative liver assessment.

EUS-guided Attenuation Imaging (ATI): Attenuation Imaging (ATI) will be performed during the diagnostic EUS to quantitatively assess hepatic steatosis. Five valid ATI measurements will be obtained from both the right and left hepatic lobes under direct EUS visualization. Measurements meeting predefined quality criteria will be used for analysis.

EUS-Guided Shear Wave Elastography (SWE): Shear Wave Elastography (SWE) will be performed during the diagnostic EUS to assess liver stiffness. Ten valid measurements will be obtained from both the right and left hepatic lobes. Shear wave velocity (m/s) and tissue elasticity (kPa) will be recorded, and only measurements meeting predefined quality criteria will be included in the analysis.

FibroScan: Participants will undergo same-day FibroScan examination before EUS to confirm normal liver stiffness and steatosis. Controlled Attenuation Parameter (CAP) and Liver Stiffness Measurement (LSM) will be recorded, with at least 10 valid measurements and acceptable quality metrics required for study eligibility.

Study summary

The goal of this observational study is to establish preliminary reference values for Endoscopic Ultrasound (EUS)-guided Attenuation Imaging (ATI) and Shear Wave Elastography (SWE) in adults undergoing diagnostic EUS for non-hepatobiliary indications who have normal FibroScan findings. The main questions it aims to answer are:

What are the preliminary normal reference values for EUS-guided ATI in the right and left hepatic lobes? What are the preliminary normal reference values for EUS-guided SWE elasticity (kPa) and velocity (m/s) in the right and left hepatic lobes?

Participants will:

Undergo same-day FibroScan assessment to confirm normal liver stiffness and steatosis parameters.

Undergo EUS-guided ATI and SWE measurements of both the right and left hepatic lobes during their clinically indicated diagnostic EUS examination.

Have demographic, clinical, and laboratory information recorded for analysis.

Eligibility

Primary outcome measure(s)

• Reference values for EUS-guided Attenuation Imaging (ATI) — During the index EUS procedure (Day 0)
  To establish preliminary reference values for EUS-guided Attenuation Imaging (ATI) in the right and left hepatic lobes of adults with normal FibroScan findings. ATI values will be reported as mean ± standard deviation (SD), median (interquartile range \[IQR\]), and 95% reference intervals.
• Reference values for EUS-guided Shear Wave Elastography (SWE) elasticity — During the index EUS procedure (Day 0)
  To establish preliminary reference values for EUS-guided SWE elasticity (kPa) in the right and left hepatic lobes. Results will be reported as mean ± SD, median (IQR), and 95% reference intervals.
• Reference values for EUS-guided Shear Wave Elastography (SWE) velocity — During the index EUS procedure (Day 0)
  To establish preliminary reference values for EUS-guided SWE shear wave velocity (m/s) in the right and left hepatic lobes. Results will be reported as mean ± SD, median (IQR), and 95% reference intervals.

Trial sites (1)

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