NCT05728697|RecruitingDMCFDA Device
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Sponsor study identifier
observational
150
1 country
2
Study Start
June 1, 2021
Actual (reported)Primary Completion
October 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
January 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 1, 2021
Actual (reported)January 18, 2023
Actual (reported)February 15, 2023
Actual (reported)October 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
January 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Up to 6 months
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
Up to 6 months
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.
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).
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Adults who are overweight or obese with suspected or confirmed NAFLD/NASH planned for clinically indicated EUS with liver biopsy
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Brigham and Women's Faulkner Hospital
Boston, Massachusetts, 02130, United States
Sumida Y, Nakajima A, Itoh Y. Limitations of liver biopsy and non-invasive diagnostic tests for the diagnosis of nonalcoholic fatty liver disease/nonalcoholic steatohepatitis. World J Gastroenterol. 2014 Jan 14;20(2):475-85. doi: 10.3748/wjg.v20.i2.475.
Xiao G, Zhu S, Xiao X, Yan L, Yang J, Wu G. Comparison of laboratory tests, ultrasound, or magnetic resonance elastography to detect fibrosis in patients with nonalcoholic fatty liver disease: A meta-analysis. Hepatology. 2017 Nov;66(5):1486-1501. doi: 10.1002/hep.29302. Epub 2017 Sep 26.
Marvin Ryou, MD
Brigham and Women's Hospital
First Submitted
January 18, 2023
First Posted
February 15, 2023
Study Start
June 1, 2021
Actual (reported)Primary Completion
October 2026
EstimatedQuantitative Ultrasound With Liver Incytes for Evaluation of Non-Alcoholic Fatty Liver Disease
Contact the study team to confirm eligibility.
Eilenberg M, Munda P, Stift J, Langer FB, Prager G, Trauner M, Staufer K. Accuracy of non-invasive liver stiffness measurement and steatosis quantification in patients with severe and morbid obesity. Hepatobiliary Surg Nutr. 2021 Oct;10(5):610-622. doi: 10.21037/hbsn-20-787.
Myers RP, Pomier-Layrargues G, Kirsch R, Pollett A, Duarte-Rojo A, Wong D, Beaton M, Levstik M, Crotty P, Elkashab M. Feasibility and diagnostic performance of the FibroScan XL probe for liver stiffness measurement in overweight and obese patients. Hepatology. 2012 Jan;55(1):199-208. doi: 10.1002/hep.24624. Epub 2011 Nov 18.
Fluss R, Faraggi D, Reiser B. Estimation of the Youden Index and its associated cutoff point. Biom J. 2005 Aug;47(4):458-72. doi: 10.1002/bimj.200410135.
Termite F, Borrelli de Andreis F, Liguori A, Gasbarrini A, Attili F, Spada C, Miele L. The Role of Endoscopic Ultrasound in Assessing Portal Hypertension: A State-of-the-Art Literature Review and Evolving Perspectives. Liver Int. 2025 Apr;45(4):e16176. doi: 10.1111/liv.16176. Epub 2024 Nov 27.
Wang TJ, Jirapinyo P, Shah R, Schuster K, Papke DJ, Thompson CC, Doyon L, Lautz DB, Ryou M. EUS-guided shear wave elastography for fibrosis screening in patients with obesity and metabolic dysfunction-associated steatotic liver disease: a pilot study (with video). Gastrointest Endosc. 2025 Feb;101(2):456-462.e1. doi: 10.1016/j.gie.2024.10.054. Epub 2024 Oct 29.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
January 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
March 2, 2026
Record last verified: 2026-02
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