EUS-Guided ATI and SWE in Individuals With Normal FibroScan | NCT07714941

NCT07714941

Overview

NCT ID: NCT07714941
Lead Sponsor: Asian Institute of Gastroenterology, IndiaOTHER
Official Title: "EUS-Guided Attenuation Imaging and Shear Wave Elastography in Individuals With Normal FibroScan: Establishing Preliminary Reference Values in a Pilot Feasibility Study".
Brief 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.

Status and Timeline

Status: Not yet recruiting
Last Update Posted: Jul 20, 2026Actual
Start Date: Aug 20, 2026Estimated
Primary Completion Date: Aug 30, 2027Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: Inclusion Criteria:

Adults aged 18 years or older.

Undergoing clinically indicated diagnostic endoscopic ultrasound (EUS).

Same-day FibroScan examination available.

Controlled Attenuation Parameter (CAP) <238 dB/m.

Liver Stiffness Measurement (LSM) <7.5 kPa.

At least 10 valid FibroScan measurements.

FibroScan interquartile range (IQR)/median ≤30%.

Able and willing to provide written informed consent.

Exclusion Criteria:

Known chronic liver disease.

Hepatitis B or Hepatitis C infection.

Significant alcohol consumption.

Decompensated cirrhosis.

Portal vein thrombosis.

Ascites.

Focal liver lesion.

Previous liver surgery.

Pregnancy.

Inadequate FibroScan examination.

Poor-quality EUS-guided Attenuation Imaging (ATI) or Shear Wave Elastography (SWE) acquisition.

Incomplete study data or withdrawal of informed consent.

Study Plan

Study Type: Observational
Phase: No data available
Enrollment: 100Estimated
Primary Purpose: No data available
Allocation: No data available
Interventional Model: No data available
Masking: No data available

Contacts and Locations

Central Contacts: Aig researchContact
aigresearch7@gmail.com+919182645727

Similar Studies

Participant Group/Arms

Normal FibroScan Cohort

Adults aged 18 years or older undergoing clinically indicated diagnostic endoscopic ultrasound (EUS) for non-hepatobiliary indications who have normal FibroScan findings (Controlled Attenuation Parameter \[CAP\] \<238 dB/m and Liver Stiffness Measurement \[LSM\] \<7.5 kPa). Participants will undergo EUS-guided Attenuation Imaging (ATI) and Shear Wave Elastography (SWE) of the right and left hepatic lobes during the same EUS procedure to establish preliminary reference values and assess the feasibility and reliability of these quantitative imaging techniques.

Procedure: Endoscopic Ultrasound (EUS)

Procedure: EUS-guided Attenuation Imaging (ATI)

Procedure: EUS-Guided Shear Wave Elastography (SWE)

Procedure: FibroScan