Recruiting

Endoscopic Ultrasound

Sponsor:

Brigham and Women's Hospital

Code:

NCT05728697

Conditions

Non-Alcoholic Fatty Liver Disease

Non-alcoholic Steatohepatitis

Obesity

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Endoscopic ultrasound shear wave elastography

Study Details

Brief 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.

Conditions

Non-Alcoholic Fatty Liver Disease

Non-alcoholic Steatohepatitis

Obesity

Study ID

NCT05728697

Start date

Jun 1, 2021

Status verified date

Feb, 2026

Completion date

Jan, 2027

Anticipated

Primary completion date

Oct, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

150 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

Endoscopic ultrasound shear wave elastography

To perform the portion of the endoscopic ultrasound exam using this device, the endoscopic ultrasound probe is placed onto the surface of the stomach with the probe facing the left liver. The probe then transmits shear waves that propagate through the tissue. The waves themselves are ultrasound waves and are harmless. This is repeated 10 times on a region of interest as guided by the endoscopic ultrasound probe. The device used in question is the linear EUS (Aloka Arietta 850, Olympus America, Center Valley, PA).

Primary outcome measure

  • Accuracy of EUS-SWE in reference to the gold standard liver biopsy [ Time Frame: Up to 6 months ]
  • Optimal stiffness cutoffs for EUS-SWE based on AUROC analysis [ Time Frame: Up to 6 months ]

Central Contacts and Locations

Central contacts

Peter Konyn, MD

6177325500pkonyn@bwh.harvard.edu

Michele Ryan

6177325500mryan@bwh.harvard.edu

Locations

Brigham and Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Michele Ryan, MS

6177325500mryan@bwh.harvard.edu

Peter Konyn, MD

6177325500pkonyn@bwh.harvard.edu

Principal Investigator:

Marvin Ryou, MD

Brigham and Women's Faulkner Hospital

Recruiting

Boston, Massachusetts, United States, 02130

Contacts

Peter Konyn, MD

6177325500pkonyn@bwh.harvard.edu

Principal Investigator:

Marvin Ryou, MD

More Information

Sponsor

Brigham and Women's Hospital

Last update posted

Mar 2, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Brigham and Women's Hospital on 2026-03-02.