Using endoscopic ultrasound to assess liver stiffness in patients with fatty liver disease
Official title: Endoscopic Ultrasound Shear Wave Elastography: A Novel Tool for Fibrosis Screening in Patient With Elevated Body Mass Index and Suspected Non-Alcoholic Fatty Liver Disease or Steatohepatitis
Run by Brigham and Women's Hospital · NCT05728697 · Data updated 2026-11-12
This study is testing if a special ultrasound can help find liver damage in people with fatty liver disease who are overweight, comparing it to other methods to see which works best.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 150 (estimated) |
| Sponsor | Brigham and Women's Hospital Academic / other |
| Drugs / interventions | radiation |
| Locations | 2 sites (Boston, Massachusetts and 1 other locations) |
| Status | Recruiting |
| Started | June 1, 2021 |
| Main results expected | October 2026 |
| Study ends | January 2027 |
| Registry record updated | March 2, 2026 |
| Trial ID | NCT05728697 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adults aged 18 and older with suspected or confirmed non-alcoholic fatty liver disease and a body mass index of 25 or higher.
✕Probably not a fit
Patients who may not benefit from this study include those with inadequate liver biopsy samples or those not planned for a follow-up liver biopsy.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to evaluate the effectiveness of endoscopic ultrasound shear wave elastography (EUS-SWE) for screening liver fibrosis in patients with non-alcoholic fatty liver disease (NAFLD) and elevated body mass index. Participants will undergo routine endoscopic ultrasound as part of their clinical care, and the study will compare the accuracy of EUS-SWE against other non-invasive scoring systems like the FIB-4 score and Fibroscan. Additionally, the study seeks to establish optimal stiffness cutoffs for liver fibrosis grading using EUS-SWE in reference to liver biopsy results, which are currently considered the gold standard. The findings could lead to improved screening methods for liver fibrosis in this patient population.
Why it matters
Potential benefit: If successful, this study could provide a more accurate and non-invasive method for screening liver fibrosis in patients with fatty liver disease, potentially leading to earlier intervention.
How similar studies have gone: Other studies have shown promise in using elastography for liver fibrosis assessment, but the specific application of EUS-SWE in this population is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * Inadequate liver biopsy sample
Where it's running
-
Brigham and Women's Hospital
Boston, Massachusetts, United States Recruiting -
Brigham and Women's Faulkner Hospital
Boston, Massachusetts, United States Recruiting
Study contacts
- Principal investigator: Marvin Ryou, MD — Brigham and Women's Hospital
- Study coordinator: Peter Konyn, MD
- Email: pkonyn@bwh.harvard.edu
- Phone: 6177325500
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.