Endoscopic Ultrasound Shear Wave Elastography in Patients With Non-alcoholic Fatty Liver Disease

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorBrigham and Women's Hospital

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

Inadequate liver biopsy sample

Trial design

Treatments tested in this trial

  • Endoscopic ultrasound shear wave elastography

Treatment groups

150 Participants
are divided into 1 treatment group

Sponsors and collaborators