A Study to Evaluate Liver Stiffness With Shear Wave Elastography
A Prospective Study of Endoscopic Ultrasound Shear Wave Elastography for Assessment of Liver Fibrosis
1 other identifier
interventional
63
1 country
1
Brief Summary
The purpose of the study is to assess the diagnostic accuracy of Endoscopic Ultrasound (EUS) shear wave elastography in liver fibrosis staging in both normal subjects and subjects with advanced liver fibrosis/cirrhosis
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 18, 2021
CompletedFirst Posted
Study publicly available on registry
October 28, 2021
CompletedStudy Start
First participant enrolled
January 19, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 12, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
January 12, 2023
CompletedResults Posted
Study results publicly available
November 30, 2023
CompletedNovember 30, 2023
November 1, 2023
12 months
October 18, 2021
November 11, 2023
November 11, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Median Endoscopic Ultrasound (EUS) Shear Wave Elastography
EUS shear wave elastography accuracy obtained by Elastic modulus measurements automatically calculated and a median of 10 readings is generated. Measured as kilopascals (kPA)
baseline
Study Arms (1)
Subjects undergoing EUS shear wave elastography
EXPERIMENTALSubject who are eligible will undergo EUS for clinical indications. EUS shear wave measurements will be gathered and studied to determine diagnostic accuracy when compared to MR Elastography.
Interventions
Software to determine stiffness of liver for evaluating liver fibrosis.
Eligibility Criteria
You may qualify if:
- Adults over 18 years of age who are undergoing EUS procedures.
- Subjects with history of chronic liver disease, advanced fibrosis or cirrhosis
- Subjects without any history of chronic liver disease
- Subjects who underwent MR elastography within six (6) months of enrollment will be eligible to participate in the study.
- Subjects able to give appropriate consent to the study or have an appropriate representative to do so.
You may not qualify if:
- Subjects who may have MRI-incompatible metal implants/devices.
- Subjects with severe claustrophobia who may not tolerate MR elastography.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
Study Sites (1)
Mayo Clinic in Rochester
Rochester, Minnesota, 55905, United States
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: 39601324DERIVED
Related Links
Results Point of Contact
- Title
- Vinay Chandrasekhara, M.D.
- Organization
- Mayo Clinic
Study Officials
- PRINCIPAL INVESTIGATOR
Vinay Chandrasekhara, MD
Mayo Clinic
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
October 18, 2021
First Posted
October 28, 2021
Study Start
January 19, 2022
Primary Completion
January 12, 2023
Study Completion
January 12, 2023
Last Updated
November 30, 2023
Results First Posted
November 30, 2023
Record last verified: 2023-11
Data Sharing
- IPD Sharing
- Will not share