Health TrialsbyHealthPanel

Endoscopic Ultrasound Shear Wave Elastography Study

ConditionsMASLDMASHFibrosis, LiverChronic Liver Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorOlympus Corporation of the Americas

About this trial

This study shall be a prospective, multicenter, single arm, consecutive, interventional study conducted in a post-market setting using commercially available devices. Consecutive, eligible patients with clinical suspicion of MASLD or MASH reporting for an endoscopic ultrasound and liver biopsy for evaluation of fibrosis will be enrolled. EUS Shear Wave Elastography and Attenuation Imaging technologies will be compared to liver biopsy and FibroScan results and other non-invasive fibrosis screening modalities . The data collected during this study will be evaluated in accordance with the procedures set forth in the protocol. The main question\[s\] it aims to answer are:

* Establish optimal cutoffs for EUS-SWE in reference to liver biopsies staging system for liver fibrosis * Evaluate the diagnostic performance of EUS-SWE compared to FibroScan (VCTE) and to other non-invasive fibrosis screening modalities (screening scores).

Participants will undergo:

* Endoscopic Ultrasound with Shear Wave Elastography (SWE) and Attenuation Imaging (ATI) * Liver biopsy * FibroScan

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

18 years of age or older

Willing and able to provide informed consent

Patient scheduled to undergo EUS with liver biopsy, either same session or separately; if separate, liver biopsy should be performed within 3 months of the EUS (either before or after) with no interval bariatric procedure/surgery or weight change of >10% total body weight

Patient scheduled to undergo or have undergone FibroScan, which should be performed within 3 months of the EUS (either before or after) with no interval bariatric procedure/surgery or weight change of >10% total body weight

Disqualifiers

Patients with surgically altered anatomy that precludes adequate endosonographic visualization of the liver parenchyma

Prior history of Hepatitis B or C infection

Decompensated cirrhosis (GI bleeding, ascites, encephalopathy)

Histological evidence of other concomitant chronic liver disease on biopsy

Trial population

Patients with chronic liver disease

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

  • Endoscopic Ultrasound Shear Wave Elastography (EUS) and Attenuation Imaging

    Device

    EUS combines ultrasound technology with endoscopy to gain an internal vantage point to obtain higher resolution ultrasound images. Shear Wave is a software option on the ultrasound system EUS that provides an advanced measure and dynamic display of tissue stiffness which is being evaluated for use in assessing liver fibrosis. Attenuation Imaging (ATI) is a novel application that provides the capability to quantify and color-code the changes in attenuation coefficient of the liver that may arise with changes in liver composition (e.g., increased fat levels).

  • FibroScan

    Device

    A small ultrasound probe to measure the velocity of a sound wave passing through the liver. This is converted into kilopascals (kPa), which is used to assess liver fibrosis.

  • Liver biopsy

    Device

    A biopsy of liver tissue could be obtained under endoscopic ultrasound guidance, interventional radiology (percutaneously), or surgically. Endoscopic Ultrasound-guided liver biopsy provides high resolution images of left lobe of the liver and a good portion of the right lobe of the liver. This, coupled with Doppler capability, allows the physician to direct the biopsy needle safely into the liver for sampling under real time image guidance.

Treatment groups

300 Participants
are divided into 1 treatment group
Group A: All subjects enrolled3 interventions

Trial outcomes

Primary outcomes

1

Shear Wave Elastography (SWE) vs liver biopsy METAVIR staging system

Establish optimal cutoffs for EUS-SWE cutoffs in reference to liver biopsies on METAVIR staging system for significant fibrosis (F0-1 vs F2-4), advanced fibrosis (F0-2 vs F3-4), and cirrhosis (F0-3 vs F4) based on area under the receiver operator characteristics (AUROC) curve analysis.

Time frame
During study data analysis

Secondary outcomes

1

SWE vs FibroScan and other non-invasive fibrosis screening modalities ( screening scores)

Evaluate the diagnostic performance of EUS-SWE compared to FibroScan (VCTE) and to other non-invasive fibrosis screening modalities (e.g., Fibrosis-4 Score (FIB-4), AST to Platelet Ratio Index (APRI), and NAFLD Fibrosis Score (NFS)).

Time frame
During study analysis
2

Correlation of EUS-SWE to fibrosis staging (from liver biopsy).

Evaluate the correlation of EUS-SWE to fibrosis staging (from liver biopsy).

Time frame
During study analysis
3

Correlation of EUS-ATI to steatosis score (from liver biopsy)

Evaluate the correlation of EUS-ATI to steatosis score (from liver biopsy).

Time frame
During study analysis

Other outcomes

Sponsors and contacts

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Olympus Corporation of the Americas

Lead sponsor

Source ClinicalTrials.gov
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