Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects undergoing EUS shear wave elastography | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endoscopic Ultrasound Shear Wave Elastography | Device | Software to determine stiffness of liver for evaluating liver fibrosis. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Vinay Chandrasekhara, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39601324 | Derived | 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. |
| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | EUS Shear Wave Elastography | Subjects who underwent EUS for clinical indications. EUS shear wave measurements were gathered and studied to determine diagnostic accuracy when compared to Magnetic Resonance (MR) Elastography. Endoscopic Ultrasound Shear Wave Elastography: Software to determine stiffness of liver for evaluating liver fibrosis. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | EUS Shear Wave Elastography | Subjects who underwent EUS for clinical indications. EUS shear wave measurements were gathered and studied to determine diagnostic accuracy when compared to MR Elastography. Endoscopic Ultrasound Shear Wave Elastography: Software to determine stiffness of liver for evaluating liver fibrosis. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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) | Data was not collected or analyzed for 34 subjects. | Posted | Median | Full Range | kPA | baseline |
|
Adverse Events were collected from baseline to end of study, approximately 1 day
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | EUS Shear Wave Elastography | Subjects who underwent EUS for clinical indications. EUS shear wave measurements were gathered and studied to determine diagnostic accuracy when compared to MR Elastography. Endoscopic Ultrasound Shear Wave Elastography: Software to determine stiffness of liver for evaluating liver fibrosis. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vinay Chandrasekhara, M.D. | Mayo Clinic | 507-284-2687 | Chandrasekhara.Vinay@mayo.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 1, 2021 | Nov 9, 2023 | Prot_SAP_000.pdf |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| 0 |
| 63 |
| 0 |
| 63 |
| 0 |
| 63 |
Not provided
Not provided
Not provided