Endoscopic ultrasound shear wave elastography for measuring liver fibrosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, multicenter, single-arm, consecutive registry enrolling up to 300 adults with suspected MASLD or MASH who are scheduled for endoscopic ultrasound with liver biopsy. Participants will undergo EUS with shear wave elastography (SWE) and attenuation imaging (ATI), a FibroScan (VCTE), and liver biopsy, with FibroScan and biopsy performed within three months of the EUS. The study will compare EUS-SWE and ATI measurements to histologic fibrosis staging and FibroScan results to establish optimal EUS-SWE cutoffs and diagnostic performance. Data will be collected at up to six U.S. sites over an expected 18-month enrollment period and analyzed against predefined protocol procedures.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. 18 years of age or older
2. Willing and able to provide informed consent
3. 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
4. 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
5. BMI \>/=28
6. 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 Criteria:

1. Patients with surgically altered anatomy that precludes adequate endosonographic visualization of the liver parenchyma
2. Prior history of Hepatitis B or C infection
3. Decompensated cirrhosis (GI bleeding, ascites, encephalopathy)
4. Histological evidence of other concomitant chronic liver disease on biopsy
5. Inadequate liver biopsy
6. Prior history of or current excess alcohol consumption (\>140 g/week and \>210 g/week for females and males, respectively) documented in EMR

Where it's running

• Hoag Memorial Hospital
  Newport Beach, California, United States Recruiting
• Brigham and Women's Hospital
  Boston, Massachusetts, United States Recruiting
• Geisinger Medical Center
  Danville, Pennsylvania, United States Recruiting

Study contacts

• Principal investigator: Marvin Ryou, MD — Brigham and Women's Hospital, Boston, MA
• Study coordinator: Heather Golden, MSc, CCRP
• Email: Heather.Golden@olympus.com
• Phone: 734-740-4642

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.