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The EUS ShearWave Elastography Liver Fibrosis Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04115046
Recruitment Status : Completed
First Posted : October 3, 2019
Last Update Posted : September 9, 2021
Sponsor:
Collaborator:
Geisinger Clinic
Information provided by (Responsible Party):
Olympus Corporation of the Americas

Study Description
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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.

Condition or disease Intervention/treatment
Liver Fibroses Device: ShearWave Elastography (SWE) in Endoscopic Ultrasound (EUS) Device: FibroScan Device: ALOKA ARIETTA 850 -

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).
Study Design
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Study Type : Observational
Actual Enrollment : 52 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pilot Study Evaluating Endoscopic Ultrasound With ShearWave Elastography for Diagnosis and Staging of Liver Fibrosis
Actual Study Start Date : July 14, 2020
Actual Primary Completion Date : April 26, 2021
Actual Study Completion Date : May 17, 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
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)
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.

Device: FibroScan
manufactured by Echosens

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


Outcome Measures
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Primary Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All consenting, eligible patients reporting for an ultrasound and/or liver biopsy for evaluation of fibrosis.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04115046


Locations
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United States, Pennsylvania
Geisinger Medical Center
Danville, Pennsylvania, United States, 17822-3069
Sponsors and Collaborators
Olympus Corporation of the Americas
Geisinger Clinic
Investigators
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Principal Investigator: David Diehl, MD Geisinger Clinic
More Information
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Responsible Party: Olympus Corporation of the Americas
ClinicalTrials.gov Identifier: NCT04115046    
Other Study ID Numbers: 2018-GI-ShearWave
First Posted: October 3, 2019    Key Record Dates
Last Update Posted: September 9, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All IPD that underlie results in a publication will be shared.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: Data will be accessible starting 6 months after publication

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Liver Cirrhosis
Fibrosis
Pathologic Processes
Liver Diseases
Digestive System Diseases