title: Single-session percutaneous ethanol ablation of early-stage hepatocellular carcinoma with a multipronged injection needle: results of a pilot clinical study.
abstract: OBJECTIVE
  To investigate the feasibility, safety, and efficacy of single-session ethanol ablation with multipronged needles in the treatment of early-stage hepatocellular carcinoma (HCC).
  
  
  METHODS
  A pilot clinical study enrolled 20 patients with Child-Pugh A-B cirrhosis (15 men and 5 women 53-84 years old [mean 70.3 years old ± 8.3, median 72 years old]) and with 25 HCC tumors 1.2-3.8 cm in longest diameter (mean 2.3 cm ± 0.6) located in unfavorable locations for radiofrequency (RF) ablation. Ethanol ablation was performed under moderate sedation using a multipronged injection needle (Quadra-Fuse; REX Medical, Conshohocken, Pennsylvania) and ultrasound guidance. Follow-up period ranged from 12-24 months (mean 15.9 months ± 4.6, median 16 months) and included contrast-enhanced computed tomography (CT) or magnetic resonance (MR) imaging performed 1 month after treatment and at 3-month intervals thereafter.
  
  
  RESULTS
  The treatment protocol was successfully completed in all patients (technical success rate 100%). No major complications were observed. A single treatment session with injection of 5-26 mL of ethanol (mean 9.5 mL ± 5.5) resulted in complete tumor ablation at 1 month CT or MR imaging in 21 (84%) of 25 tumors. A second treatment session increased the number of tumors with complete response (CR) to 23 of 25 (primary effectiveness rate 92%). Tumor progression was observed in three cases during the follow-up period, for a rate of confirmed CR of 80% (20 of 25).
  
  
  CONCLUSIONS
  Ethanol ablation performed with a multipronged injection needle was not associated with any major complications and resulted in a high rate of confirmed CR. This technique offers an alternative to RF ablation for single-session treatment of early-stage HCC.
authors.affiliation: Division of Diagnostic Imaging and Intervention, Department of Liver Transplantation, Cisanello University Hospital, Building No 30C, Via Paradisa 2, IT-56124, Pisa, Italy. lencioni@med.unipi.it
authors.forename: Riccardo
authors.initials: R
authors.lastname: Lencioni
authors.forename: Laura
authors.initials: L
authors.lastname: Crocetti
authors.forename: Dania
authors.initials: D
authors.lastname: Cioni
authors.forename: Clotilde Della
authors.initials: CD
authors.lastname: Pina
authors.forename: Filippo
authors.initials: F
authors.lastname: Oliveri
authors.forename: Paolo
authors.initials: P
authors.lastname: De Simone
authors.forename: Maurizia
authors.initials: M
authors.lastname: Brunetto
authors.forename: Franco
authors.initials: F
authors.lastname: Filipponi
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D006528:Carcinoma, Hepatocellular / Q000000981:diagnostic imaging / Q000628:therapy*; D004621:Embolization, Therapeutic / Q000379:methods*; D000431:Ethanol / Q000008:administration & dosage* / Q000009:adverse effects; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D015552:Injections, Intralesional / Q000295:instrumentation* / Q000379:methods; D008113:Liver Neoplasms / Q000000981:diagnostic imaging / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D009339:Needles; D010865:Pilot Projects; D012597:Sclerosing Solutions / Q000008:administration & dosage* / Q000009:adverse effects; D016896:Treatment Outcome; D014463:Ultrasonography
chemical_list: D012597:Sclerosing Solutions; D000431:Ethanol