title: Randomized controlled trial for hepatocellular carcinoma with portal vein thrombosis: intra-arterial iodine-131-iodized oil versus medical support.
abstract: Portal vein thrombosis is a poor prognostic factor in patients with hepatocellular carcinoma (HCC) and a contraindication for chemoembolization. Intra-arterial injection of 131I-iodized oil which does not modify arterial flow, is feasible in this condition. The aim of this prospective randomized controlled trial was to compare the efficacy of treatment with radiolabeled oil (treated group) versus medical support (control group) in patients with stage I or II HCC (classification of Okuda) with portal vein thrombosis.
  
  
  METHODS
  Twenty-seven HCC patients (26 males, 1 female), aged 53-79 yr, with portal vein thrombosis were randomly assigned to Lipiocis group (n = 14) or Control group (n = 13). Additional injections of radiolabeled oil were given 2, 5, 8 and 12 mo after initial therapy. Medical support treatment consisted of: tamoxifen (n = 5), 5 FU intravenously (n = 1), NSAIDs or corticosteroids (n = 5). Efficacy was evaluated according to survival rate (Kaplan-Meier method; log rank test), AFP serum values (measured at 2, 5, 8 and 12 mo) and angiography.
  
  
  RESULTS
  The two groups were comparable (Child's classification, Okuda's classification, liver function tests, location of the thrombus). Tolerance was excellent in the Treated group. The actuarial survival curves were significantly different (p < 0.01) between the two groups, the survival rates (Cl 95%) at 3, 6 and 9 mo being 71% (48%-95%), 48% (12%-55%), 7% (1%-31%) for the Treated group; and 10% (1%-33%), 0% and 0% for the Control group.
  
  
  CONCLUSIONS
  Intra-arterial hepatic injection of 131I-labeled iodized oil is a safe and effective palliative treatment of HCC with portal vein thrombosis.
authors.affiliation: Service de Radiologie, Hôpital Sud, Rennes, France.
authors.forename: J L
authors.initials: JL
authors.lastname: Raoul
authors.forename: D
authors.initials: D
authors.lastname: Guyader
authors.forename: J F
authors.initials: JF
authors.lastname: Bretagne
authors.forename: R
authors.initials: R
authors.lastname: Duvauferrier
authors.forename: P
authors.initials: P
authors.lastname: Bourguet
authors.forename: D
authors.initials: D
authors.lastname: Bekhechi
authors.forename: Y M
authors.initials: YM
authors.lastname: Deugnier
authors.forename: M
authors.initials: M
authors.lastname: Gosselin
mesh_terms: D000305:Adrenal Cortex Hormones / Q000627:therapeutic use; D000368:Aged; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000627:therapeutic use; D006528:Carcinoma, Hepatocellular / Q000188:drug therapy / Q000401:mortality / Q000532:radiotherapy*; D005260:Female; D005472:Fluorouracil / Q000627:therapeutic use; D006499:Hepatic Artery; D006801:Humans; D007269:Injections, Intra-Arterial; D007457:Iodine Radioisotopes / Q000008:administration & dosage / Q000627:therapeutic use*; D007459:Iodized Oil / Q000008:administration & dosage / Q000627:therapeutic use*; D008113:Liver Neoplasms / Q000188:drug therapy / Q000401:mortality / Q000532:radiotherapy*; D008297:Male; D008875:Middle Aged; D009360:Neoplastic Cells, Circulating; D010166:Palliative Care / Q000379:methods*; D011169:Portal Vein; D011446:Prospective Studies; D015996:Survival Rate; D013629:Tamoxifen / Q000627:therapeutic use
chemical_list: D000305:Adrenal Cortex Hormones; D000894:Anti-Inflammatory Agents, Non-Steroidal; D007457:Iodine Radioisotopes; D013629:Tamoxifen; D007459:Iodized Oil; D005472:Fluorouracil