Comparing Lipiodol/Ethanol With Drug-eluting Beads (DEB) for Hepatocellular Carcinoma

• Number of Patients with Post-Embolization Syndrome [ Time Frame: Week 6 Post Intervention ] [ Designated as safety issue: Yes ]
  Count of patients with post-embolizaation syndrome reported which includes fatigue, anorexia, nausea, fever.
  
  

• Patients with Encephalopathy After Embolization [ Time Frame: Week 6 Post Intervention ] [ Designated as safety issue: Yes ]
  Count of patients who had encephalopathy after embolization.
  
  
• Changes in Quality of Life [ Time Frame: Baseline and Week 6 After Intervention ] [ Designated as safety issue: No ]
  Changes (noted as a score of 0 [not at all] to 4 [very much]; total score ranges from 1-180) in the different aspects of the Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep) quality of life questionnaire (a 45-item self-report instrument designed to measure health-related quality of life in patients with hepatobiliary cancers).
  
  
• Comparison of Liver Function Tests Results [ Time Frame: Day 0 and Week 6 Post Intervention ] [ Designated as safety issue: No ]
  List of results for alpha-fetoprotein (AFP), albumin (Alb), alanine transaminase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALKP), blood urea nitrogen (BUN), creatinine (Cr), glomerular filtration rate (GFR), Bilirubin (T, D), platelets (Plt), international normalized ratio (INR - prothrombin time), Child-Pugh score.
  
  
• Imaging Response [ Time Frame: Week 6 Post Intervention ] [ Designated as safety issue: No ]
  Determined by European Association for the Study of the Liver (EASL) criteria a set of non-invasive criteria for HCC in cirrhotic patients. The diagnosis is established if two imaging modalities (US, CT, magnetic resonance imaging (MRI)) show a coincidental nodule with arterial hypervascularization regardless of AFP levels, or if a single modality shows a lesion when the AFP levels are more than 400 ng/ml. Histologic diagnosis is required if the patient is non-cirrhotic or if the lesions are smaller than 2 cm.
  
  
• Number of Patients with Successful Liver Transplant [ Time Frame: Week 6 After Intervention ] [ Designated as safety issue: No ]
  
• Overall Survival [ Time Frame: Week 6 After Intervention ] [ Designated as safety issue: No ]
  Determined by date of death or date censored.
  
  

This is a randomized prospective study with two arms, Drug-Eluting Beads with doxorubicin (DEB) and lipiodol ethanol mixture (LEM), with the goal to show non-inferiority of LEM, which if true will facilitate a simple alternative to DEBs. Patients will be randomized to one arm of the study and will remain in that arm if they need to have more embolization in the future. Both of the mentioned methods (DEB and LEM) fall within the standard of care.