Liver Fibroses
Conditions
Brief summary
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
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).
Interventions
DEVICEShearWave Elastography (SWE) in Endoscopic Ultrasound (EUS)
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.
DEVICEFibroScan
manufactured by Echosens
DEVICEALOKA ARIETTA 850 -
manufactured by Hitachi Healthcare - included on the system is the ShearWave measurement software
Sponsors
Geisinger Clinic
Olympus Corporation of the Americas
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Analyze the correlation between SWE of liver and FibroScan of liver with histologic fibrosis stage using Spearman Correlation Coefficient. | 6 months | Use ANOVA with Tukey Range test to evaluate the level of significance of difference in SWE results across fibrosis stages. |
Countries
United States
Outcome results
None listed