Endoscopic Ultrasound Shear Wave Elastography in Patients With Non-alcoholic Fatty Liver Disease
Recruiting now
Conditions studied: Non-Alcoholic Fatty Liver Disease, Non-alcoholic Steatohepatitis, Obesity
In brief
The goal of this observation study is to assess whether endoscopic ultrasound shear wave elastography (EUS-SWE) may be a useful tool for liver fibrosis screening in patients with elevated body mass index and non alcoholic fatty liver disease as compared to other non-invasive screening modalities, which have traditionally had less accurate results in this population. The main questions it aims to answer are: * Determine accuracy of EUS-SWE for liver fibrosis screening compared to other non-invasive scoring systems, such as the FIB-4 score and Fibroscan in patients with elevated body mass index * Establish optimal stiffness (kPa) cutoffs for liver fibrosis grading for EUS-SWE for this patient population in reference to the gold standard liver biopsy, as no standard cutoffs currently exist. Participants will undergo routine endoscopic ultrasound as part of their standard clinical care and indication. Participants are consented for the procedure and undergoing the shear wave elastography. In addition to their standard ultrasound test, it takes on average an extra 2-3 minutes to perform the shear wave elastography. The procedure itself adds no additional risk to the patient and does not expose them to radiation.
Key facts
- Study ID
- NCT05728697
- Run by
- Brigham and Women's Hospital
- People needed
- 150
- Starts
- 2021-06-01
- Expected to finish
- 2027-01-01
- Last updated by the study team
- 2026-03-02
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- Inadequate liver biopsy sample
Where it is running
- Brigham and Women's Hospital — Boston, Massachusetts, United States (enrolling)
- Brigham and Women's Faulkner Hospital — Boston, Massachusetts, United States (enrolling)
Full record on ClinicalTrials.gov
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