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
This trial does not accept healthy volunteersQualifiers
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 population
Adults who are overweight or obese with suspected or confirmed NAFLD/NASH planned for clinically indicated EUS with liver biopsy
Trial design
Design model
Cohort
Time perspective
Cross-sectional
Treatments tested in this trial
Endoscopic ultrasound shear wave elastography
DeviceTo 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).
Treatment groups
150 Participants
are divided into 1 treatment groupGroup A: Patients with nonalcoholic fatty liver disease and elevated body mass index1 intervention
Trial outcomes
Primary outcomes
1
Accuracy of EUS-SWE in reference to the gold standard liver biopsy
Accuracy is measured by performing area under the receiver operator characteristic (AUROC) analysis for different threshold of liver fibrosis (e.g. advanced fibrosis, cirrhosis). The AUROC c-statistic number will then be statistically compared to other non-invasive modalities, such as FIB-4 and Fibroscan who will have similar AUROC curves generated as surrogate for accuracy.
Time frame
Up to 6 months2
Optimal stiffness cutoffs for EUS-SWE based on AUROC analysis
Optimal cutoffs can be derived with the Youden index in attempt to maximize sensitivity and specificity
Time frame
Up to 6 monthsSponsors and contacts
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Source ClinicalTrials.gov