Ultrasound Imaging Compared With Biopsy to Assess Liver Scarring
Compares an endoscopic ultrasound scan with liver biopsy in adults with suspected fatty liver disease.
Plain-language title generated from the registry record
Registry title: Endoscopic Ultrasound Shear Wave Elastography Study
Key facts
- Where
- Boston, Danville, and Newport Beach, United StatesSee the 3 sites
Where in United States
- Brigham and Women's HospitalBoston, United StatesTaking people
- Geisinger Medical CenterDanville, United StatesTaking people
- Hoag Memorial HospitalNewport Beach, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Olympus Corporation of the Americas
- Trial code
- NCT06592820
- Record updated
- 10 November 2026
- Original description
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:Read full original descriptionShow less
Endoscopic Ultrasound With Shear Wave Elastography for the Assessment of Liver Disease
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
Inclusion: 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; BMI >/=28; Clinical suspicion of MASLD (hepatic steatosis with at least one of five cardiometabolic risk factors: 1) overweight or obesity, 2) elevated glucose, 3) low HDL-C, 4) hypertension, and/or 5) hypertriglyceridemia) or MASH (additionally characterized by the presence of inflammation and hepatocellular ballooning) with or without fibrosis, as determined by non-invasive or minimally invasive techniques (e.g. abdominal ultrasound, FibroScan).
Exclusion: Prior history of Hepatitis B or C infection; Histological evidence of other concomitant chronic liver disease on biopsy; Prior history of or current excess alcohol consumption (>140 g/week and >210 g/week for females and males, respectively) documented in EMR; Decompensated cirrhosis (GI bleeding, ascites, encephalopathy); Patients with surgically altered anatomy that precludes adequate endosonographic visualization of the liver parenchyma; Inadequate liver biopsy.