The EUS ShearWave Elastography Liver Fibrosis Study

Liver Fibroses Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04115046
• Other study ID #: 2018-GI-ShearWave
• Status: Completed
• Start date: July 14, 2020
• Est. completion date: May 17, 2021

Study information

• Verified date: September 2021
• Source: Olympus Corporation of the Americas
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: May 17, 2021
• Est. primary completion date: April 26, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Fibrosis
• Liver Cirrhosis
• Liver Fibroses

Intervention

Device:
• ShearWave 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.
• FibroScan
manufactured by Echosens
• ALOKA ARIETTA 850 -
manufactured by Hitachi Healthcare - included on the system is the ShearWave measurement software

Locations

Country	Name	City	State
United States	Geisinger Medical Center	Danville	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Olympus Corporation of the Americas	Geisinger Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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