The EUS ShearWave Elastography Liver Fibrosis Study

Olympus Corporation of the Americas52 enrolled

Overview

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.

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).

Study Type

OBSERVATIONAL

Enrollment

Conditions

Liver Fibroses

Interventions

ShearWave Elastography (SWE) in Endoscopic Ultrasound (EUS)DEVICE

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.

FibroScanDEVICE

manufactured by Echosens

ALOKA ARIETTA 850 -DEVICE

manufactured by Hitachi Healthcare - included on the system is the ShearWave measurement software

Eligibility

Sex: ALLMin age: 18 YearsMax age: 100 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. ≥ 18 years of age 2. Willing and able to provide informed consent 3. Undergoing diagnostic EUS procedure with liver biopsy 4. Baseline CBC, CMP, INR within 3 months Exclusion Criteria: 1. Contraindication to EUS-guided liver biopsy 2. Baseline platelet count \<50,000 3. Baseline INR \>1.5 4. Patient is a prisoner

Locations (1)

Geisinger Medical Center

Danville, Pennsylvania, United States

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 6 months

Data from ClinicalTrials.gov

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