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Completed

NCT Number: NCT04115046

The EUS ShearWave Elastography Liver Fibrosis Study

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.

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Key information

Conditions

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

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Geisinger Medical Center

Danville, Pennsylvania, 17822-3069, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

FibroScan

Device

manufactured by Echosens

ALOKA ARIETTA 850 -

Device

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

Primary outcomes

  1. Analyze the correlation between SWE of liver and FibroScan of liver with histologic fibrosis stage using Spearman Correlation Coefficient.

    Time frame: 6 months

    Use ANOVA with Tukey Range test to evaluate the level of significance of difference in SWE results across fibrosis stages.

  2. Analyze the correlation between SWE of liver and FibroScan of liver with histologic fibrosis stage using Spearman Correlation Coefficient.

    Time frame: 6 months

    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.

Sponsors and collaborators

Lead sponsor

Olympus Corporation of the Americas

Industry

Collaborators

  • Geisinger Clinic

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Oct 3, 2019
Registry last updated
Sep 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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