Non-invasive Evaluation of Portal Hypertension in Patients With Compensated Advanced Chronic Liver Disease by Liver Stiffness Measurement Using Liver Incytes
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Portal Hypertension
- Sponsor
- Indiana University
- Enrollment
- 70
- Locations
- 1
- Primary Endpoint
- Platelet Count for Participants With Compensated Advanced Chronic Liver Disease
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
Samer Gawrieh
Professor of Clinical Medicine
Indiana University
Eligibility Criteria
Inclusion Criteria
- •Adults aged 18 years or older
- •Ability to provide informed consent
- •Planned standard of care upper endoscopy to screen for varices
- •Planned standard of care transjugular liver biopsy with portal pressure measurement
Exclusion Criteria
- •Inability or refusal to provide informed consent
- •Fasting for less than three hours prior to the scan
- •Subject is a pregnant or lactating female
- •Subject with current, significant alcohol consumption
- •Patients with a pacemaker or defibrillator
- •Acute hepatitis defined as AST/ALT \> 500 U/L
- •post liver transplantation
Outcomes
Primary Outcomes
Platelet Count for Participants With Compensated Advanced Chronic Liver Disease
Time Frame: 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
Liver Stiffness Measurements for Participants With Compensated Advanced Chronic Liver Disease With and Without Esophageal Varices Upon Esophagogastroduodenoscopy (EGD)
Time Frame: 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.