Advanced Cirrhosis, Advanced Fibrosis, Chronic Liver Disease
Conditions
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.
Interventions
Software to determine stiffness of liver for evaluating liver fibrosis.
Sponsors
Mayo Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 63 |
| Total | 63 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Protocol Violation | 13 |
| Overall Study | Withdrawal by Subject | 21 |
Baseline characteristics
| Characteristic | EUS Shear Wave Elastography |
|---|---|
| Age, Continuous | 52 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 60 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 60 Participants |
| Region of Enrollment United States | 63 participants |
| Sex: Female, Male Female | 32 Participants |
| Sex: Female, Male Male | 31 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 63 |
| other Total, other adverse events | 0 / 63 |
| serious Total, serious adverse events | 0 / 63 |
Outcome results
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)
Time frame: baseline
Population: Data was not collected or analyzed for 34 subjects.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| EUS Shear Wave Elastography | Median Endoscopic Ultrasound (EUS) Shear Wave Elastography | 0.11 kPA |