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Non-hepatobiliary IndicationsEUS ATI&SWENCT07714941

EUS-Guided ATI and SWE in Individuals With Normal FibroScan

An observational study of Non-hepatobiliary Indications, run by Asian Institute of Gastroenterology, India at 1 site in India.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-hepatobiliary Indications
What is being tested?
Endoscopic Ultrasound (EUS), EUS-guided Attenuation Imaging (ATI) and EUS-Guided Shear Wave Elastography (SWE)
Type of treatment
Surgery or procedure
How many people
100 participants
Where
1 siteIndia
Study dates
20 Aug 2026to 20 Sep 2027
How long will I take part?
1 Day
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

  • Known chronic liver disease.
  • Hepatitis B or Hepatitis C infection.
  • Significant alcohol consumption.
  • Decompensated cirrhosis.
  • Portal vein thrombosis.
  • Ascites.
Show all 12Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

India1 site
  • AIG Hospitals

    Hyderabad, Telangana, 500032

    Aig research, MD, DM, 09182645727, aigresearch7@gmail.com

    Dr. Sundeep Lakhtakia, MD, DM

Other trials in India

About this study

Official title: "EUS-Guided Attenuation Imaging and Shear Wave Elastography in Individuals With Normal FibroScan: Establishing Preliminary Reference Values in a Pilot Feasibility Study".

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?

Read more

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.

Read the detailed description

Vibration-controlled transient elastography (FibroScan) with Liver Stiffness Measurement (LSM) and Controlled Attenuation Parameter (CAP) is widely used for the non-invasive assessment of liver fibrosis and steatosis. Although these techniques have demonstrated good diagnostic performance, they have several limitations, including technical failure in obese individuals, reduced accuracy in the presence of ascites or narrow intercostal spaces, and the inability to obtain real-time image-guided measurements from specific areas of the liver.

Endoscopic ultrasound (EUS) provides high-resolution imaging of both hepatic lobes through the stomach and duodenum, allowing quantitative assessment of liver tissue under direct visualization. Recent advances have enabled the integration of Attenuation Imaging (ATI), which quantifies hepatic steatosis, and Shear Wave Elastography (SWE), which measures liver stiffness by estimating tissue elasticity and shear wave velocity, into EUS platforms. These techniques may overcome several limitations of conventional transabdominal elastography and have the potential to provide more reliable liver tissue characterization.

Before EUS-guided ATI and SWE can be evaluated as diagnostic tools for liver disease, normal reference values in individuals without liver disease must be established. Currently, there are limited data regarding normal EUS-guided ATI and SWE measurements, particularly in healthy adults with normal FibroScan findings. Establishing these reference ranges is essential for interpreting future studies involving patients with hepatic steatosis and chronic liver disease.

This prospective, single-center, observational pilot feasibility study aims to establish preliminary reference values for EUS-guided ATI and SWE in adults undergoing diagnostic EUS for non-hepatobiliary indications who have normal FibroScan examinations. A total of 100 participants will be enrolled after confirming normal liver stiffness (LSM <7.5 kPa) and steatosis (CAP <238 dB/m), along with adequate FibroScan quality criteria.

During the clinically indicated EUS examination, quantitative liver assessment will be performed without introducing additional invasive procedures beyond standard EUS. Attenuation Imaging will be obtained from both the right and left hepatic lobes, with five valid measurements acquired per lobe. Shear Wave Elastography will also be performed in both lobes, with ten valid measurements obtained per lobe. Measurements will be accepted only if predefined quality criteria are met, including acceptable correlation coefficients, propagation maps, and reliability indices. Acquisition time, technical success, and measurement reproducibility will also be recorded.

The primary outcome of the study is to establish preliminary reference values for EUS-guided ATI, SWE elasticity (kPa), and SWE velocity (m/s) for both hepatic lobes. Secondary objectives include evaluating the technical feasibility and reliability of EUS-guided quantitative liver assessment, assessing agreement between right and left hepatic lobe measurements, determining correlations between ATI and FibroScan CAP, evaluating correlations between SWE and FibroScan LSM, and documenting acquisition times for both techniques.

The findings from this pilot study will provide foundational reference data for EUS-guided quantitative liver imaging and support the design of larger validation studies investigating the role of EUS-guided ATI and SWE in the diagnosis and monitoring of hepatic steatosis and fibrosis.

Being tested
Endoscopic Ultrasound (EUS), EUS-guided Attenuation Imaging (ATI), EUS-Guided Shear Wave Elastography (SWE), FibroScan
Keywords
Endoscopic Ultrasound (EUS), Attenuation Imaging (ATI), Shear Wave Elastography (SWE), Liver Fibrosis, Controlled Attenuation Parameter (CAP), Liver Stiffness Measurement (LSM)
Medical subject headings
Liver Cirrhosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Endoscopic Ultrasound (EUS)Procedure or 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 or 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 or 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.

  • FibroScanProcedure or 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.

Study groups in NCT07714941
Study groupRoleWhat they receive
Normal FibroScan CohortAdults 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.
Receives: Procedure: Endoscopic Ultrasound (EUS); Procedure: EUS-guided Attenuation Imaging (ATI); Procedure: EUS-Guided Shear Wave Elastography (SWE); Procedure: FibroScan

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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.

    Measured: 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.

    Measured: During the index EUS procedure (Day 0)

Secondary outcomes (6)
  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.

    Measured: 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.

    Measured: 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.

    Measured: 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).

    Measured: During the index EUS procedure (Day 0)

  5. Correlation between SWE and FibroScan Liver Stiffness Measurement (LSM)

    To evaluate the correlation between EUS-guided SWE measurements and FibroScan Liver Stiffness Measurement (LSM).

    Measured: During the index EUS procedure (Day 0)

  6. Acquisition time

    To determine the time required to complete EUS-guided ATI and SWE measurements during the diagnostic EUS examination.

    Measured: During the index EUS procedure (Day 0)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jul 2026
  2. Study start20 Aug 2026 (estimated)
  3. Primary completion30 Aug 2027 (estimated)
  4. Study completion20 Sep 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
100 participants (estimated)
Target duration
1 Day
IDs, dates and publications
ClinicalTrials.gov ID
NCT07714941
Sponsor's protocol ID
EUS-ATI&SWE
Acronym
EUS ATI&SWE
Status last verified
Jul 2026
First submitted
15 Jul 2026
Last updated
20 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Non-hepatobiliary Indications, run by Asian Institute of Gastroenterology, India at 1 site in India.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Aig research (+919182645727, aigresearch7@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Reference values for EUS-guided Attenuation Imaging (ATI) (time frame: During the index EUS procedure (Day 0)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2026.

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