title: Adjuvant hepatic intra-arterial iodine-131-lipiodol following curative resection of hepatocellular carcinoma: a prospective randomized trial.
abstract: BACKGROUND
  The purpose of the present study was to determine whether intrahepatic injection of (131)I-lipiodol (Lipiodol) is effective against recurrence of surgically resected hepatocellular carcinoma (HCC).
  
  
  METHODS
  From June 2001 through March 2007, this nationwide multi-center prospective randomized controlled trial enrolled 103 patients 4-6 weeks after curative resection of HCC with complete recovery (52: Lipiodol, 51: Control). Follow-up was every 3 months for 1 year, then every 6 months. Primary and secondary endpoints were recurrence-free survival (RFS) and overall survival (OS), respectively, both of which were evaluated by the Kaplan-Meier technique and summarized by the hazard ratio (HR). The design was based on information obtained from a similar trial that had been conducted in Hong Kong.
  
  
  RESULTS
  The Lipiodol group showed a small, and nonsignificant, improvement over control in RFS (HR = 0.75; 95 % confidence interval [95 % CI] 0.46-1.23; p = 0.25) and OS (HR = 0.88; 95 % CI 0.51-1.51; p = 0.64). Only two serious adverse events were reported, both with hypothyroidism caused by (131)I-lipiodol and hepatic artery dissection during angiography.
  
  
  CONCLUSIONS
  The randomized trial provides insufficient evidence to recommend the routine use of (131)I-lipiodol in these patients.
authors: General Surgery, Singapore General Hospital, Outram Road, Singapore, 169608, Singapore. gsucyf@sgh.com.sg
authors: A Y F
authors: AY
authors: Chung
authors: L L P J
authors: LL
authors: Ooi
authors: D
authors: D
authors: Machin
authors: S B
authors: SB
authors: Tan
authors: B K P
authors: BK
authors: Goh
authors: J S
authors: JS
authors: Wong
authors: Y M
authors: YM
authors: Chen
authors: P C N
authors: PC
authors: Li
authors: M
authors: M
authors: Gandhi
authors: C H
authors: CH
authors: Thng
authors: S W K
authors: SW
authors: Yu
authors: B S
authors: BS
authors: Tan
authors: R H G
authors: RH
authors: Lo
authors: A M M
authors: AM
authors: Htoo
authors: K H
authors: KH
authors: Tay
authors: F X
authors: FX
authors: Sundram
authors: A S W
authors: AS
authors: Goh
authors: S P
authors: SP
authors: Chew
authors: K H
authors: KH
authors: Liau
authors: P K H
authors: PK
authors: Chow
authors: K H
authors: KH
authors: Tay
authors: Y M
authors: YM
authors: Tan
authors: P C
authors: PC
authors: Cheow
authors: C K
authors: CK
authors: Ho
authors: K C
authors: KC
authors: Soo
mesh_terms: D000368:Aged; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D006528:Carcinoma, Hepatocellular / Q000188:drug therapy* / Q000601:surgery*; D017024:Chemotherapy, Adjuvant; D004998:Ethiodized Oil / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D007269:Injections, Intra-Arterial; D007457:Iodine Radioisotopes / Q000627:therapeutic use*; D008113:Liver Neoplasms / Q000188:drug therapy* / Q000601:surgery*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D015996:Survival Rate; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D007457:Iodine Radioisotopes; D004998:Ethiodized Oil