title: Efficacy of metal and plastic stents in unresectable complex hilar cholangiocarcinoma: a randomized controlled trial.
abstract: BACKGROUND
  Endoscopic biliary stent drainage is effective in the palliative treatment of patients with hilar cholangiocarcinoma (HCA). However, no randomized controlled trial comparing the efficacy of the self-expandable metal stent (SEMS) and the plastic stent (PS) in patients with unresectable complex HCA is available.
  
  
  OBJECTIVE
  To compare the successful drainage rates of endoscopic SEMSs and PSs.
  
  
  METHODS
  A single-center, open-label randomized controlled trial.
  
  
  METHODS
  University hospital in KhonKaen, Thailand.
  
  
  METHODS
  One hundred eight patients with unresectable complex, Bismuth type II-IV HCA.
  
  
  METHODS
  Endoscopic retrograde cholangiography with unilateral SEMS or PS insertion.
  
  
  METHODS
  Successful drainage rate.
  
  
  CONCLUSIONS
  Diagnosis of HCA was made by clinical presentations, imaging studies, and clinical outcome during follow-up.
  
  
  RESULTS
  One hundred eight patients were randomly allocated to the SEMS and PS groups. Intention-to-treat analysis revealed that the successful drainage rate in the SEMS group was higher than in the PS group (70.4% vs 46.3%, P = .011). The median survival times were 126 and 49 days, respectively, in the SEMS and PS groups. The overall survival rates of the patients in both groups were statistically different by log-rank test (P = .002).
  
  
  CONCLUSIONS
  Endoscopic biliary drainage with the SEMS provides better adequacy of drainage and longer survival compared with the PS in patients with unresectable complex HCA.
authors.affiliation: Department of Medicine, KhonKaen University, KhonKaen, Thailand.
authors.forename: Apichat
authors.initials: A
authors.lastname: Sangchan
authors.forename: Worrarat
authors.initials: W
authors.lastname: Kongkasame
authors.forename: Ake
authors.initials: A
authors.lastname: Pugkhem
authors.forename: Kriangsak
authors.initials: K
authors.lastname: Jenwitheesuk
authors.forename: Pisaln
authors.initials: P
authors.lastname: Mairiang
mesh_terms: D000368:Aged; D001650:Bile Duct Neoplasms / Q000150:complications*; D001653:Bile Ducts, Intrahepatic; D016009:Chi-Square Distribution; D018281:Cholangiocarcinoma / Q000150:complications*; D002760:Cholangiopancreatography, Endoscopic Retrograde; D002761:Cholangitis / Q000209:etiology; D002779:Cholestasis / Q000209:etiology / Q000628:therapy*; D004322:Drainage / Q000295:instrumentation*; D005260:Female; D006801:Humans; D057194:Intention to Treat Analysis; D053208:Kaplan-Meier Estimate; D008297:Male; D008670:Metals; D008875:Middle Aged; D010166:Palliative Care; D010195:Pancreatitis / Q000209:etiology; D010969:Plastics; D019106:Postoperative Hemorrhage / Q000209:etiology; D016717:Sphincterotomy, Endoscopic / Q000009:adverse effects; D015607:Stents / Q000009:adverse effects
chemical_list: D008670:Metals; D010969:Plastics