A Study to Evaluate Liver Stiffness With Shear Wave Elastography

Not Applicable

Completed

• Conditions: Advanced Fibrosis; Advanced Cirrhosis; Chronic Liver Disease
• Interventions: Device: Endoscopic Ultrasound Shear Wave Elastography

• Registration Number: NCT05097963
• Lead Sponsor: Mayo Clinic

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

Detailed Description

This is a prospective, paired study. Study subjects who are scheduled to undergo EUS at Mayo Clinic will be identified through Epic. Chart review will be performed including review of prior imaging, medical history, and laboratory results as available in Epic to determine study eligibility. Subjects without history of chronic liver disease (screened by low FIB-4 score) and those with known advanced fibrosis/cirrhosis will be eligible for the study. Eligible study subjects will then be contacted either before, or at the time of their endoscopy procedure to discuss study participation. All subjects will then receive standard clinical care based on the indication for the EUS procedure. During the EUS procedure, study subjects with undergo shear wave measurements obtained in a non-invasive manner as part of the endosonographic evaluation of the liver. 10 measurements (including shear wave velocity (Vs), elastic modulus (E)) will be obtained for point SWE (pSWE). Measurements will be obtained from both left and right lobes of liver unless technically infeasible to do so. Study subjects will then undergo a paired MR elastography (same day or at later date) after completion of EUS and only if consistent and reliable shear wave measurements were obtained (e.g., VsN \> 70%(reliability index of each measurement expressed in percentages), IQR/M (interquartile range/ Median) is \<15% for Vs and \<30% for E). Enrolled study subjects who had undergone a previous MRE (within 6 months of enrollment) would be eligible for the study, without the need to undergo further research MRE. After completion of MR elastography, the subjects will then continue through their routine clinical care and will not be followed up by research staff. The expected duration of subject participation is anticipated to begin at the time of study enrollment and terminate after completion of MR elastography. There will be no additional follow up.

Study Timeline

• Study First Submitted: 2021-10-18
• Study First Submitted QC: 2021-10-18
• Study First Posted: 2021-10-28
• Study Start: 2022-01-19
• Primary Completion: 2023-01-12
• Study Completion: 2023-01-12
• Status Verified: 2023-11
• Results First Submitted: 2023-11-11
• Results First Submitted QC: 2023-11-11
• Last Update Submitted: 2023-11-11
• Results First Posted: 2023-11-30
• Last Update Posted: 2023-11-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 63

Inclusion Criteria

• 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.

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Exclusion Criteria

• Subjects who may have MRI-incompatible metal implants/devices.
• Subjects with severe claustrophobia who may not tolerate MR elastography.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Subjects undergoing EUS shear wave elastography	Endoscopic Ultrasound Shear Wave Elastography	Subject 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.

Primary Outcome Measures

Name	Time	Method
Median Endoscopic Ultrasound (EUS) Shear Wave Elastography	baseline	EUS shear wave elastography accuracy obtained by Elastic modulus measurements automatically calculated and a median of 10 readings is generated. Measured as kilopascals (kPA)

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States