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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Observational
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Massachusetts
Brigham and Women's Faulkner Hospital
RECRUITING
Boston
Brigham and Women's Hospital
RECRUITING
Boston
Contact Information
Primary
Peter Konyn, MD
pkonyn@bwh.harvard.edu
6177325500
Backup
Michele Ryan
mryan@bwh.harvard.edu
6177325500
Time Frame
Start Date: 2021-06-01
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 150
Treatments
Patients with nonalcoholic fatty liver disease and elevated body mass index
Patients who have BMI \>=25 and suspected nonalcoholic fatty liver disease based on imaging, laboratory workup, or clinical history. Patients are included in the study if they have been selected for routine clinical endoscopic ultrasound (can be for any indication) with liver biopsy either during the same session or within 6 months.
Sponsors
Leads: Brigham and Women's Hospital

This content was sourced from clinicaltrials.gov