The EUS ShearWave Elastography Liver Fibrosis Study

Study Overview
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Brief Summary
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The study objective is to demonstrate the clinical performance of ShearWave Elastography (SWE) in Endoscopic Ultrasound (EUS) when compared to FibroScan for evaluation of liver fibrosis.

Detailed Description
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This study has been designed as prospective, single center, single arm, consecutive, blinded, pilot study conducted in a post-market setting using commercially available devices to evaluate the effectiveness of Endoscopic Ultrasound with ShearWave Elastography to estimate hepatic fibrosis in patients with chronic liver disease. It is anticipated that the data from this study will support the need for additional clinical trials. All consenting, eligible patients reporting for an ultrasound and/or liver biopsy for evaluation of fibrosis meeting the inclusion criteria will be consecutively enrolled into the study and assigned a unique study identification number. A total of 52 subjects will be enrolled and treated at a single study site in the US. Enrollment is expected to be completed within 6 months. Each subject will undergo both procedures (FibroScan and EUS with SW Elastography), End of study will be reached after pathology results have been obtained (within a week of the initial procedure).

Official Title
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Pilot Study Evaluating Endoscopic Ultrasound With ShearWave Elastography for Diagnosis and Staging of Liver Fibrosis

Conditions
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Liver Fibroses

Intervention / Treatment
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* Device: ShearWave Elastography (SWE) in Endoscopic Ultrasound (EUS)
* Device: FibroScan
* Device: ALOKA ARIETTA 850 -


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ≥ 18 years of age Willing and able to provide informed consent Undergoing diagnostic EUS procedure with liver biopsy Baseline CBC, CMP, INR within 3 months Exclusion Criteria: Contraindication to EUS-guided liver biopsy Baseline platelet count <50,000 Baseline INR >1.5 Patient is a prisoner

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Treatment Arm<br>Consecutive, eligible patients reporting for an ultrasound and liver biopsy for evaluation of fibrosis will be enrolled. Each subject will undergo both procedures (FibroScan and EUS with SW Elastography). | Device: ShearWave Elastography (SWE) in Endoscopic Ultrasound (EUS)<br>* ShearWave Measurement is a software option available on the ARIETTA 850 that uses transient pulses to generate shear waves in the body. The tissue's elasticity is directly deduced by measuring the speed of wave propagation.<br>Device: FibroScan<br>* manufactured by Echosens<br>Device: ALOKA ARIETTA 850 -<br>* manufactured by Hitachi Healthcare - included on the system is the ShearWave measurement software<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analyze the correlation between SWE of liver and FibroScan of liver with histologic fibrosis stage using Spearman Correlation Coefficient. | Use ANOVA with Tukey Range test to evaluate the level of significance of difference in SWE results across fibrosis stages. | 6 months | 
| Analyze the correlation between SWE of liver and FibroScan of liver with histologic fibrosis stage using Spearman Correlation Coefficient. | Construct receiver operating characteristic curves (ROC) to determine which liver section (left or right) had best accuracy of prediction of fibrosis stage and compared overall accuracy between SWE and TE. | 6 months |