Surrogate Markers of Portal Pressure
Condition: Portal Hypertension; Cirrhosis
MeSH terms: Liver Cirrhosis; Hypertension, Portal; Hypertension; Fibrosis
Study type: Interventional

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.
    

Detailed description: 
      Subjects will be recruited from the outpatient setting of the West Haven VA Medical Center
      and the Yale Liver Clinic. Subjects between 18-85 years of age with compensated cirrhosis due
      to chronic hepatitis C virus (HCV) infection who will be starting anti-viral therapy to treat
      HCV within the next 3 months will be eligible for this study. 33 subjects (assuming 10% loss
      to follow-up) will be recruited and their participation will last from 6-12 months. The
      expected duration of the study is 2 years.

      The primary end point of the study is to correlate the change (from baseline to after
      completing anti-HCV therapy) in ICG retention test, LS and SS as measured by ARFI with HVPG.
      After consent has been obtained, subjects will undergo ICG retention test, ARFI imaging and
      HVPG measurements before and after HCV therapy. Blood samples, demographic and clinical data
      will be collected before and after HCV therapy. Correlations between changes in HVPG and
      changes in ICG, LS and SS will be assessed. With 30 patients , we will have 80% power to
      perform a hypothesis test of the Pearson correlation assuming an observed correlation of 0.70
      and a two-sided type I error rate of 0.05.
    

Intervention name(s): HVPG; Indocyanine Green Retention test; Liver stiffness measurement; Spleen stiffness measurement
Intervention type(s): Procedure; Drug; Device; Device
Intervention description(s): HVPG will be performed by placing a placing a 7F venous catheter into a supra-hepatic vein and then advancing a 5F balloon-tipped catheter into the right hepatic vein. Wedged hepatic venous pressure (WHVP) and free hepatic venous pressure (FHVP) will be measured by connection to an external transducer and polygraph (PowerLab, ADInstruments Inc., Colorado Springs, CO). After inflating the balloon catheter, adequacy of the occlusion will be established by injection of a small amount of radiologic contrast medium. Hepatic Venous Pressure gradient (HVPG) will be calculated as the difference between WHVP and FHVP.; As decribed in arm descriptions; As decribed in arm descriptions; perfromed by ARFI; As decribed in arm descriptions; performed by ARFI
Other intervention name(s): Hepatic Venous Portal Gradient; ICG test; LS; SS
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: ICG; ARFI; portal hypertension; cirrhosis; diagnostic study