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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

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Ultrasound, Biopsies, MRI scans

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
  • "Participants will undergo routine endoscopic ultrasound as part of their standard clinical care and indication."
  • "In addition to their standard ultrasound test, it takes on average an extra 2-3 minutes to perform the shear wave elastography."
  • "Identification of patients with suspected NAFLD/NASH and early stage fibrosis is crucial for prompt clinical management in weight loss and optimization of metabolic disorders for reversal of fibrosis, but the gold standard of liver biopsy can be impractical due to high costs and risk of sampling error and procedural complications."
  • "Many elastography modalities exist, including Fibroscan, magnetic resonance elastography (MRE), and shear wave elastography (SWE)."
  • "Endoscopic ultrasound (EUS) approaches to elastography may hold several technical advantages over transabdominal in patients with obesity due to EUS-SWE's ability to visualize the liver parenchyma under a thin sub-centimeter gastric or duodenal wall, unlike transabdominal approaches in which the quality may be impacted by a thick abdominal wall."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this 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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Official 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

Study sites (2)

MA