Streamlining Radioembolization for Small HCC

Streamlining Radioembolization for HCC ≤ 5 cm With Y90 Resin Microspheres : Multicenter Prospective Registry Study

In patients who has no sign suggesting high lung shunt fraction (TIPS, hepatic vein invasion, hepatic vein enhancement on arterial phase, dysmorphic intratumoral vessel, tumor size < 5cm), radioembolization is performed without MAA scan with SIR-Spheres. This prospective registry will prove that the selection criteria is accurate and streamlining radioembolization is feasible and safe.

Inclusion Criteria:

• adults aged >18 years
• Patients diagnosed with hepatocellular carcinoma histologically and/or radiologically (LI-RADS 4 or 5)
• hepatocellular carcinoma 5cm or smaller
• Tumor number is 3 or smaller
• Dysmorphic intratumoral vessel is absent or smaller than 3 mm
• Child-Pugh class A
• ECOG 0 or 1
• the following lab should be met. A. Leukocytes ≥ 1,000/µL and ≤ 20,000/µL B. Hemoglobin ≥ 6.0 g/dL (transfusion allowed to meet this criterion) C. Total bilirubin ≤ 2.0 mg/dL D. Platelet ≥ 40,000/µL E. International normalized ratio (INR) ≤ 2.0 for patients not taking anticoagulants F. Aspartate transaminase (AST) ≤ 800 IU/L (i.e., ≤ 20X upper normal limit) G. Alanine transaminase (ALT) ≤ 800 IU/L (i.e., ≤ 20X upper normal limit) H. Creatinine ≤ 2.5 mg/dL (if patient is receiving hemodialysis, no upper limit of creatinine)
• Patients with a life expectancy of >3 mo
• Patients who have adequately understood the clinical trial and consented in writing
• Nonpregnant women of childbearing potential

Exclusion Criteria:

1. Hepatic vein invasion on CT/MRI
2. Marked enhancement of portal vein or hepatic vein on arterial phase of CT/MRI
3. Dysmorphic intratumoral vessel ≥3mm
4. Patient with transjugular intrahepatic portosystemic shunt
5. Patient with bilioenteric anastomosis or biliary stent
6. Patient with centrilobular emphysema or interstitial lung disease
7. main portal vein invasion