Surrogate Markers of Portal Pressure

• Status: Completed
• Trial end date: 2019-07-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a prospective longitudinal study that will evaluate if changes (pre and post therapy) in indocyanine green (ICG) retention test and liver stiff ness (LS) and spleen stiffness (SS) as measured by acoustic radiofrequency impulse (ARFI) correlate with changes in portal pressure as determined by the hepatic vein pressure gradient (HVPG) in patients with compensated hepatitis C virus (HCV) cirrhosis undergoing antiviral therapy.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: VA Connecticut Healthcare System

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