Chronic Advanced Liver Disease, Portal Hypertension
Conditions
Brief summary
This is a cross sectional study that evaluates the relationship between LSM (liver stiffness measurement) by Liver Incytes in patients with cACLD (compensated advanced chronic liver disease) and manifestations of portal hypertension.
Detailed description
The purpose of this study is to assess the severity of portal hypertension in people with compensated advanced chronic liver disease (cACLD) who have not undergone liver transplant by measuring liver stiffness with the Liver Incytes device (Velacur) and comparing the performance of LSM (liver stiffness measurement) via Velcaur and transient elastography via FibroScan to esophageal varices.
Interventions
DIAGNOSTIC_TESTVelacur
Ultrasound elasticity imaging
Sponsors
Sonic Incytes
Indiana University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Masking description
This is an open label study in that all participants will receive the same study procedures. Participants only receive this Velacur intervention if they are enrolled in this trial.
Intervention model description
All participants will undergo quantitative ultrasound with Velacur by Sonic Incytes by a certified technician.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Adults aged 18 years or older 2. Ability to provide informed consent 3. Planned standard of care upper endoscopy to screen for varices 4. Planned standard of care transjugular liver biopsy with portal pressure measurement
Exclusion criteria
1. Inability or refusal to provide informed consent 2. Fasting for less than three hours prior to the scan 3. Subject is a pregnant or lactating female 4. Subject with current, significant alcohol consumption 5. Patients with a pacemaker or defibrillator 6. Acute hepatitis defined as AST/ALT \> 500 U/L 7. Ascites 8. post liver transplantation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Liver Stiffness Measurements for Participants With Compensated Advanced Chronic Liver Disease With and Without Esophageal Varices Upon Esophagogastroduodenoscopy (EGD) | one day | Comparing the performance of Velacur by Sonic Incytes to transient elastography via FibroScan® in the same patient population to determine if either test is more accurate in correlating with compensated advanced chronic liver disease (cACLD) for participants with and without esophageal varices. |
| Platelet Count for Participants With Compensated Advanced Chronic Liver Disease | one day | Comparing the platelet count in the same patient population to determine Velacur's accuracy in correlating with compensated advanced chronic liver disease (cACLD) for participants with and without esophageal varices |
Other
| Measure | Time frame | Description |
|---|---|---|
| Correlation of Velacur Measurements to Non-Invasive Blood Markers for Predicting Advanced Fibrosis | one day | This was initially included in our study protocol as an outcome measurement. However, we realized that these markers were not being routinely collected and the data are simply not available. Therefore, no outcome data are or can be included for this measurement. |
Countries
United States
Participant flow
Recruitment details
70 participants enrolled in the study. The images from the Velacur device for all of the subjects were reviewed by the company. Only 33 of the enrolled participants had a valid Velacur study so results are reported only for these 33 participants. The remaining 37 participants were considered to have withdrawn from the study.
Pre-assignment details
70 participants enrolled in the study. The images from the Velacur device for all of the subjects were reviewed by the company. Only 33 of the enrolled participants had a valid Velacur study so results are reported only for these 33 participants. The remaining 37 participants were considered to have withdrawn from the study.
Participants by arm
| Arm | Count |
|---|---|
| Liver Incytes Patients with compensated advanced chronic liver disease (cACLD) who have not undergone liver transplantation will be scanned with Liver Incytes. | 33 |
| Total | 33 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | 37 scans were determined by the sponsor to be invalid. | 37 |
Baseline characteristics
| Characteristic | Liver Incytes |
|---|---|
| Age, Continuous | 58 years STANDARD_DEVIATION 11.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 30 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 3 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 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 | 3 Participants |
| Race (NIH/OMB) White | 28 Participants |
| Region of Enrollment United States | 33 Participants |
| Sex: Female, Male Female | 8 Participants |
| Sex: Female, Male Male | 25 Participants |
| transient elastography via FibroScan, liver steatosis | 262 dB/m STANDARD_DEVIATION 73 |
| transient elastography via FibroScan, liver stiffness | 37.8 kPa STANDARD_DEVIATION 24.1 |
| Velacur, liver steatosis | 313 dB/m STANDARD_DEVIATION 76 |
| Velacur, liver stiffness | 9.9 kPa STANDARD_DEVIATION 3.4 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 70 |
| other Total, other adverse events | 0 / 70 |
| serious Total, serious adverse events | 0 / 70 |
Outcome results
Primary
Liver Stiffness Measurements for Participants With Compensated Advanced Chronic Liver Disease With and Without Esophageal Varices Upon Esophagogastroduodenoscopy (EGD)
Comparing the performance of Velacur by Sonic Incytes to transient elastography via FibroScan® in the same patient population to determine if either test is more accurate in correlating with compensated advanced chronic liver disease (cACLD) for participants with and without esophageal varices.
Time frame: one day
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants Without Evidences of Esophageal Varices | Liver Stiffness Measurements for Participants With Compensated Advanced Chronic Liver Disease With and Without Esophageal Varices Upon Esophagogastroduodenoscopy (EGD) | liver stiffness with Velacur | 9.6 kPa | Standard Deviation 3.9 |
| Participants Without Evidences of Esophageal Varices | Liver Stiffness Measurements for Participants With Compensated Advanced Chronic Liver Disease With and Without Esophageal Varices Upon Esophagogastroduodenoscopy (EGD) | liver stiffness with FibroScan | 26.5 kPa | Standard Deviation 21.9 |
| Participants With Evidence of Esophageal Varices | Liver Stiffness Measurements for Participants With Compensated Advanced Chronic Liver Disease With and Without Esophageal Varices Upon Esophagogastroduodenoscopy (EGD) | liver stiffness with Velacur | 10.1 kPa | Standard Deviation 3.2 |
| Participants With Evidence of Esophageal Varices | Liver Stiffness Measurements for Participants With Compensated Advanced Chronic Liver Disease With and Without Esophageal Varices Upon Esophagogastroduodenoscopy (EGD) | liver stiffness with FibroScan | 43.3 kPa | Standard Deviation 23.5 |
Primary
Platelet Count for Participants With Compensated Advanced Chronic Liver Disease
Comparing the platelet count in the same patient population to determine Velacur's accuracy in correlating with compensated advanced chronic liver disease (cACLD) for participants with and without esophageal varices
Time frame: one day
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants Without Evidences of Esophageal Varices | Platelet Count for Participants With Compensated Advanced Chronic Liver Disease | 91.2 in 100000 per microliter of blood | Standard Deviation 37.7 |
| Participants With Evidence of Esophageal Varices | Platelet Count for Participants With Compensated Advanced Chronic Liver Disease | 138 in 100000 per microliter of blood | Standard Deviation 71 |
Other Pre-specified
Correlation of Velacur Measurements to Non-Invasive Blood Markers for Predicting Advanced Fibrosis
This was initially included in our study protocol as an outcome measurement. However, we realized that these markers were not being routinely collected and the data are simply not available. Therefore, no outcome data are or can be included for this measurement.
Time frame: one day
Population: During the course of this study, we realized that these markers were not being routinely collected and the data are simply not available. Therefore, no outcome data are or can be included for this measurement