title: Transarterial chemoembolisation (TACE) combined with endovascular implantation of an iodine-125 seed strand for the treatment of hepatocellular carcinoma with portal vein tumour thrombosis versus TACE alone: a two-arm, randomised clinical trial.
abstract: OBJECTIVE
  There was no standard treatment for hepatocellular carcinoma with portal vein tumour thrombosis (PVTT). This prospective, randomised, two-arm clinical trial aims to investigate the feasibility, safety and effectiveness of transarterial chemoembolisation (TACE) combined with the endovascular implantation of an iodine-125 seed strand for the treatment of hepatocellular carcinoma with portal vein tumour thrombosis versus conventional TACE.
  
  
  METHODS
  Eighty-five patients who met the eligibility requirements were randomly assigned to receive the treatment of TACE combined with the endovascular implantation of an iodine-125 seed strand (43 cases) or conventional TACE (42 cases). The end points were survival time, complications related to the procedure and adverse events.
  
  
  RESULTS
  No significant differences in baseline characteristics were observed between groups. The mean and median survival times were 221.7 ± 16.3 days [95 % confidence interval (CI) 189.8-253.6 days] and 210.0 ± 17.5 days (95 % CI 175.8-244.2 days) in group A and 155.1 ± 7.9 days (95 % CI 139.6-170.5 days) and 154.0 ± 11.2 days (95 % CI 133.2-176.0 days) in group B (P = 0.000). The 90-, 180- and 360-day cumulative survival rates were 97.6, 58.9 and 12.3 % in group A and 92.5, 30.7 and 0 % in group B (P = 0.000).
  
  
  CONCLUSIONS
  Transarterial chemoembolisation combined with the endovascular implantation of an iodine-125 seed strand is feasible, safe and effective in the treatment for hepatocellular carcinoma with PVTT.
authors.affiliation: Department of Interventional Radiology, Zhongshan Hospital, Fudan University, 180 Fenglin Road, Shanghai, 200032, China.
authors.forename: Minjie
authors.initials: M
authors.lastname: Yang
authors.forename: Zhuting
authors.initials: Z
authors.lastname: Fang
authors.forename: Zhiping
authors.initials: Z
authors.lastname: Yan
authors.forename: Jianjun
authors.initials: J
authors.lastname: Luo
authors.forename: Lingxiao
authors.initials: L
authors.lastname: Liu
authors.forename: Wen
authors.initials: W
authors.lastname: Zhang
authors.forename: Linlin
authors.initials: L
authors.lastname: Wu
authors.forename: Jingqin
authors.initials: J
authors.lastname: Ma
authors.forename: Qinghui
authors.initials: Q
authors.lastname: Yang
authors.forename: Qingxin
authors.initials: Q
authors.lastname: Liu
mesh_terms: D019917:Blood Vessel Prosthesis Implantation; D006528:Carcinoma, Hepatocellular / Q000150:complications / Q000401:mortality / Q000628:therapy*; D016461:Chemoembolization, Therapeutic; D003131:Combined Modality Therapy; D057510:Endovascular Procedures; D005240:Feasibility Studies; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007457:Iodine Radioisotopes / Q000627:therapeutic use*; D008113:Liver Neoplasms / Q000150:complications / Q000401:mortality / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D011169:Portal Vein; D011379:Prognosis; D011446:Prospective Studies; D015996:Survival Rate; D020246:Venous Thrombosis / Q000209:etiology / Q000401:mortality / Q000628:therapy*
chemical_list: D007457:Iodine Radioisotopes