EUS-Guided ATI and SWE in Individuals With Normal FibroScan

NCT07714941 | Not Yet Recruiting DMC

• 1 other identifier: EUS-ATI&SWE
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-hepatobiliary Indications

Keywords

Endoscopic Ultrasound (EUS); Attenuation Imaging (ATI); Shear Wave Elastography (SWE); Liver Fibrosis; Controlled Attenuation Parameter (CAP); Liver Stiffness Measurement (LSM)

Outcome Measures

Primary Outcomes (3)

• Reference values for EUS-guided Attenuation Imaging (ATI)

  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.

  During the index EUS procedure (Day 0)

• Reference values for EUS-guided Shear Wave Elastography (SWE) elasticity

  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.

  During the index EUS procedure (Day 0)

• Reference values for EUS-guided Shear Wave Elastography (SWE) velocity

  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.

  During the index EUS procedure (Day 0)

Secondary Outcomes (6)

• Technical success rate

  During the index EUS procedure (Day 0)

• Measurement reliability

  During the index EUS procedure (Day 0)

• Agreement between right and left hepatic lobe measurements

  During the index EUS procedure (Day 0)

• Correlation between ATI and FibroScan CAP

  During the index EUS procedure (Day 0)

• Correlation between SWE and FibroScan Liver Stiffness Measurement (LSM)

  During the index EUS procedure (Day 0)

Study Arms (1)

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

Interventions

EUS-guided Attenuation Imaging (ATI) PROCEDURE

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.

Normal FibroScan Cohort

EUS-Guided Shear Wave Elastography (SWE) PROCEDURE

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.

Normal FibroScan Cohort

FibroScan PROCEDURE

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.

Normal FibroScan Cohort

Endoscopic Ultrasound (EUS) PROCEDURE

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.

Normal FibroScan Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults aged 18 years or older undergoing clinically indicated diagnostic endoscopic ultrasound (EUS) for non-hepatobiliary indications at AIG Hospitals will be screened for eligibility. Participants with normal FibroScan findings, defined as a Controlled Attenuation Parameter (CAP) \<238 dB/m and Liver Stiffness Measurement (LSM) \<7.5 kPa, who meet all eligibility criteria and provide written informed consent will be enrolled in the study.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Asian Institute of Gastroenterology, India: lead

Study Sites (1)

AIG Hospitals

Hyderabad, Telangana, 500032, India

Location

MeSH Terms

Conditions

Liver Cirrhosis

Interventions

Endoscopic Ultrasound-Guided Fine Needle Aspiration

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biopsy, Fine-Needle; Biopsy, Needle; Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Image-Guided Biopsy; Specimen Handling; Ultrasonography, Interventional; Ultrasonography; Diagnostic Imaging; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Investigative Techniques

Central Study Contacts

Aig research

CONTACT

+919182645727; aigresearch7@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Gastroenterology

Study Record Dates

• First Submitted: July 15, 2026
• First Posted: July 20, 2026
• Study Start (Estimated): August 20, 2026
• Primary Completion (Estimated): August 30, 2027
• Study Completion (Estimated): September 20, 2027
• Last Updated: July 20, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)