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Observational Study of Endoscopic Ultrasound Shear Wave Elastography for Fatty Liver Disease

This observational study is looking at how well a special imaging test, Endoscopic Ultrasound Shear Wave Elastography (EUS-SWE), can detect liver scarring (fibrosis) in people with non-alcoholic fatty liver disease (NAFLD) and obesity. EUS-SWE uses sound waves during an endoscopic ultrasound to measure liver stiffness, which can indicate fibrosis. Researchers want to see if EUS-SWE is more accurate than other non-invasive tests for this group of patients. They will compare EUS-SWE results to a liver biopsy, which is currently the most accurate way to check for liver scarring. The study also aims to find the best stiffness measurements for EUS-SWE to identify different levels of liver scarring. You might be able to join if you are an adult aged 18 or older, have suspected or confirmed NAFLD, a BMI of 25 or higher, and are already scheduled for an endoscopic ultrasound with a follow-up liver biopsy. The study plans to include 150 participants.

Study design
This is an observational study, meaning researchers will observe and collect information without providing new treatments. It aims to enroll 150 participants.
What's involved
You would undergo an endoscopic ultrasound where the EUS-SWE device is used. This procedure involves placing a probe on your stomach to face your liver.
Compensation
Not stated in the trial record.
Follow-up
Your EUS-SWE results will be compared to your liver biopsy results up to 6 months after the procedure.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05728697

Endoscopic Ultrasound Shear Wave Elastography in Patients With Non-alcoholic Fatty Liver Disease

Recruiting
Not specifiedAges 18+Observational
Brigham and Women's Hospital
~150 participants
Updated 2026-03-02 on ClinicalTrials.gov
What's tested:Endoscopic ultrasound shear wave elastography

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Accuracy of EUS-SWE in reference to the gold standard liver biopsy
Measured over Up to 6 months
+1 more outcome measured

Conditions

Non-Alcoholic Fatty Liver Disease
Non-alcoholic Steatohepatitis
Obesity

Explore related trials

Nonalcoholic Fatty Liver DiseaseNonalcoholic SteatohepatitisObesity

Where it's being run

2 sites across 1 states
Massachusetts2

Study leadership

  • Marvin Ryou, MD · PRINCIPAL_INVESTIGATOR · Brigham and Women's Hospital

Who to contact

Peter Konyn, MD
[email protected]
6177325500
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Adults 18 years or older
Planned for clinically indicated endoscopic ultrasound with plan for follow up liver biopsy
Suspected or confirmed non alcoholic fatty liver disease prior to procedure
Body mass index \>=25

Exclusion

Inadequate liver biopsy sample

What this trial measures

  • Accuracy of EUS-SWE in reference to the gold standard liver biopsyUp to 6 months

    Accuracy is measured by performing area under the receiver operator characteristic (AUROC) analysis for different threshold of liver fibrosis (e.g. advanced fibrosis, cirrhosis). The AUROC c-statistic number will then be statistically compared to other non-invasive modalities, such as FIB-4 and Fibroscan who will have similar AUROC curves generated as surrogate for accuracy.

  • Optimal stiffness cutoffs for EUS-SWE based on AUROC analysisUp to 6 months

    Optimal cutoffs can be derived with the Youden index in attempt to maximize sensitivity and specificity