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EUS-Guided ATI and SWE in Individuals With Normal FibroScan

ConditionNon-hepatobiliary Indications
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAsian Institute of Gastroenterology, India

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Known chronic liver disease.

Hepatitis B or Hepatitis C infection.

Significant alcohol consumption.

Decompensated cirrhosis.

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Endoscopic Ultrasound (EUS)

    Procedure/Surgery

    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)

    Procedure/Surgery

    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)

    Procedure/Surgery

    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

    Procedure/Surgery

    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.

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: Normal FibroScan Cohort4 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
During the index EUS procedure (Day 0)
2

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.

Time frame
During the index EUS procedure (Day 0)
3

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.

Time frame
During the index EUS procedure (Day 0)

Secondary outcomes

1

Technical success rate

To determine the proportion of participants in whom acceptable EUS-guided ATI and SWE measurements are successfully acquired according to predefined quality criteria.

Time frame
During the index EUS procedure (Day 0)
2

Measurement reliability

To evaluate the reliability and reproducibility of EUS-guided ATI and SWE measurements using predefined quality parameters.

Time frame
During the index EUS procedure (Day 0)
3

Agreement between right and left hepatic lobe measurements

To assess agreement between ATI and SWE measurements obtained from the right and left hepatic lobes.

Time frame
During the index EUS procedure (Day 0)
4

Correlation between ATI and FibroScan CAP

To evaluate the correlation between EUS-guided ATI measurements and FibroScan Controlled Attenuation Parameter (CAP).

Time frame
During the index EUS procedure (Day 0)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Asian Institute of Gastroenterology, India

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: