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Endoscopic Ultrasound Shear Wave Elastography in Patients With Non-alcoholic Fatty Liver Disease
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
Who can join
Ages 18 and older · All sexes
Full eligibility 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
About the study
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.
What is being tested
- Endoscopic ultrasound shear wave elastography (device)
Sponsor: Brigham and Women's Hospital · Participants: 150 · Started: Jun 1, 2021
Contact the study team
- Peter Konyn, MD · Phone: 6177325500
- Michele Ryan · Phone: 6177325500
Official record on ClinicalTrials.gov — NCT05728697
Locations in the U.S.
| Massachusetts | Brigham and Women's Faulkner Hospital, Boston Brigham and Women's Hospital, Boston |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.