Endoscopic Ultrasound Shear Wave Elastography Study

ConditionsMASLD MASH Fibrosis, Liver Chronic 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

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 design

Treatments tested in this trial

Endoscopic Ultrasound Shear Wave Elastography (EUS) and Attenuation Imaging
FibroScan
Liver biopsy

Treatment groups

300 Participants

are divided into 1 treatment group

Locations

Brigham and Women's Hospital02115, BostonMassachusetts, United States

Geisinger Medical Center17822, DanvillePennsylvania, United States

Sponsors and collaborators

Olympus Corporation of the Americas

Lead sponsor

Source ClinicalTrials.gov