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

Prospective Study Comparing Lipiodol Plus Ethanol Solution Compared With Drug-Eluting Beads for Trans-arterial Chemoembolization of Liver in Treatment of Hepatocellular Carcinoma

Chemoembolization of hepatocellular carcinoma lesions is an accepted and frequently used method for the palliative or curative treatment of these lesions. These attempts are being made to make these patients a better candidate for liver transplant or to provide palliation for their condition.

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.

Inclusion Criteria:

• Child-Pugh class A or B
• Biopsy proven HCC or hypervascular mass per European Association for the Study of the Liver (EASL) criteria
• Patient not a candidate for surgical resection or percutaneous ablation
• age > 18 years old and able to consent

Exclusion Criteria:

• Child-Pugh class C
• Model for End-Stage Liver Disease (MELD) score >16
• Extrahepatic disease
• Bilateral or main portal vein thrombus
• Total bilirubin > 2.2
• Serum albumin < 2.6
• Life expectancy < 2 months
• Uncorrected INR > 2
• Eastern Cooperative Oncology Group (ECOG) status > 2
• Tumor burden > 50% liver volume
• Hepatofugal portal venous flow