MedTrace Logo

EUS-Guided ATI and SWE in Individuals With Normal FibroScan

NCT07714941 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2026-07-20

No results posted yet for this 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.

Conditions

  • Non-hepatobiliary Indications

Interventions

PROCEDURE

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.

PROCEDURE

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.

PROCEDURE

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.

PROCEDURE

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.

Sponsors & Collaborators

  • Asian Institute of Gastroenterology, India

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-20
Primary Completion
2027-08-30
Completion
2027-09-20

Countries

  • India

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07714941 on ClinicalTrials.gov