The EUS ShearWave Elastography Liver Fibrosis Study

NCT04115046 | Completed FDA Device

• 1 other identifier: 2018-GI-ShearWave
• Study Type: observational
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Fibroses

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

Treatment Arm

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); Device: FibroScan; Device: ALOKA ARIETTA 850 -

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.

Treatment Arm

FibroScan DEVICE

manufactured by Echosens

Treatment Arm

ALOKA ARIETTA 850 - DEVICE

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

Treatment Arm

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All consenting, eligible patients reporting for an ultrasound and/or liver biopsy for evaluation of fibrosis.

You may qualify if:

• ≥ 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

You may not qualify if:

• Contraindication to EUS-guided liver biopsy
• Baseline platelet count \<50,000
• Baseline INR \>1.5
• Patient is a prisoner

Sponsors & Collaborators

• Olympus Corporation of the Americas: lead
• Geisinger Clinic: collaborator

Study Sites (1)

Geisinger Medical Center

Danville, Pennsylvania, 17822-3069, United States

Location

Related Publications (1)

• 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.

  PMID: 39601324 DERIVED

MeSH Terms

Conditions

Liver Cirrhosis

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• David Diehl, MD

  Geisinger Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2019
• First Posted: October 3, 2019
• Study Start: July 14, 2020
• Primary Completion: April 26, 2021
• Study Completion: May 17, 2021
• Last Updated: September 9, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will be accessible starting 6 months after publication

Locations

US (1)