Surrogate Markers of Portal Pressure
Portal Hypertension, Cirrhosis
About this trial
This is an interventional diagnostic trial for Portal Hypertension focused on measuring ICG, ARFI, portal hypertension, cirrhosis, diagnostic study
Eligibility Criteria
Inclusion Criteria:
- Age 18-85
- HCV infection (HCV-RNA positive)
- Compensated cirrhosis will be defined histologically and/or clinically (presence of compatible lab findings (platelet count ≤ 150,000, total bilirubin ≥ 2, serum albumin ≤ 3.5, INR ≥ 1.2) PLUS compatible physical exam features (cutaneous stigmata, gynecomastia in men, or splenomegaly) OR compatible radiological findings (nodular liver surface, splenomegaly, and/or collaterals). (The ultimate confirmation of the diagnosis of cirrhosis will be a baseline HVPG > 5 mmHg)
- Planned anti-HCV therapy in the next 3 months
Exclusion Criteria:
- Any clinically-evident complication of cirrhosis that defines decompensation : jaundice, ascites, variceal hemorrhage, overt hepatic encephalopathy)
- Hepatocellular carcinoma
- Co-infection with HBV or HIV
- Ongoing alcohol abuse
- Occlusive portal thrombosis,
- Presence of comorbid conditions conferring a life expectancy<1 year, history of allergy to iodides, pregnancy
Sites / Locations
- Yale-New Haven Hospital
- VA Connecticut Healthcare System
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Active Comparator
Active Comparator
Indocyanine green retention test
Liver stiffness measurement
Spleen stiffness measurement
A baseline venous sample of 5 ml of venous will be drawn for pre-infusion measurement. Under sterile conditions 0.5 mg/kg body weight of ICG will be injected into vein. Further blood samples (5 ml each) will be collected at 5, 10, 15 and 20 minute intervals after the injection from a peripheral vein in the opposite arm using another intravenous catheter. After serum is separated by centrifugation, optical densities will be measured at 804 nm using a calibrated method for measurement of ICG level s. ICG retention at 15 minutes and elimination rate constant will be calculated by fitting the serum disappearance curve to a single exponential decay equation.This will be compared to portal pressure measured by Hepatic Venous Portal Gradient (HVPG).
ARFI measurements of the liver will be obtained using a standard ultrasound probe. The patient will be lying on his back and will be asked to hold his/her breath for 2-5 seconds during measurements.These will be compared to portal pressure measured by Hepatic Venous Portal Gradient (HVPG).
ARFI measurements of the spleen will be obtained using a standard ultrasound probe. The patient will be lying on his back and will be asked to hold his/her breath for 2-5 seconds during measurements.These will be compared to portal pressure measured by Hepatic Venous Portal Gradient (HVPG).