A Study to Evaluate Liver Stiffness With Shear Wave Elastography

NCT ID: NCT05097963

Last Updated: 2023-11-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 63 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-19
• Study Completion Date: 2023-01-12

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.

Conditions

Chronic Liver Disease; Advanced Fibrosis; Advanced Cirrhosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Subjects undergoing EUS 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.

Group Type: EXPERIMENTAL

Endoscopic Ultrasound Shear Wave Elastography

Intervention Type: DEVICE

Software to determine stiffness of liver for evaluating liver fibrosis.

Interventions

Endoscopic Ultrasound Shear Wave Elastography

Software to determine stiffness of liver for evaluating liver fibrosis.

Intervention Type: DEVICE

Eligibility Criteria

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.

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Vinay Chandrasekhara

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Vinay Chandrasekhara, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 39601324 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

https://www.mayo.edu/research/clinical-trials

Mayo Clinic Clinical Trials

Other Identifiers

21-003779

Identifier Type: -

Identifier Source: org_study_id