title: Cost Efficacy of Metal Stents for Palliation of Extrahepatic Bile Duct Obstruction in a Randomized Controlled Trial.
abstract: OBJECTIVE
  Endoscopic stents are placed for palliation of extrahepatic bile duct obstruction. Although self-expandable metal stents (SEMS) remain patent longer than plastic stents, they are more expensive. We aimed to evaluate which type of stent (plastic, uncovered SEMS [uSEMS], or partially covered SEMS [pcSEMS]) is the most effective and we assessed costs.
  
  
  METHODS
  We performed a multicenter randomized trial in 219 patients at 18 hospitals in The Netherlands from February 2008 through February 2013. Patients were assigned randomly for placement of a plastic stent (n = 73), uSEMS (n = 75), or pcSEMS (n = 71) during endoscopic retrograde cholangiopancreatography. Patients were followed up for up to 1 year. Researchers were not blinded to groups. The main study end points included functional stent time and costs.
  
  
  RESULTS
  The mean functional stent times were 172 days for plastic stents, 288 days for uSEMS, and 299 days for pcSEMS (P < .005 for uSEMS and pcSEMS vs plastic). The initial placement of plastic stents (€1042 or $1106) cost significantly less than placement of SEMS (€1973 or $2094) (P = .001). However, the total cost per patient at the end of the follow-up period did not differ significantly between plastic stents (€7320 or $7770) and SEMS (€6932 or $7356) (P = .61). Furthermore, in patients with short survival times (≤3 mo) or metastatic disease, the total cost per patient did not differ between plastic stents and SEMS. No differences in costs were found between pcSEMS and uSEMS.
  
  
  CONCLUSIONS
  Although placement of SEMS (uncovered or partially covered) for palliation of extrahepatic bile duct obstruction initially is more expensive than placement of plastic stents, SEMS have longer functional time. The total costs after 1 year do not differ significantly with stent type. Dutch Clinical Trial Registration no: NTR1361.
authors: Department of Gastroenterology and Hepatology, University Medical Center Utrecht, Utrecht, The Netherlands. Electronic address: d.walter@umcutrecht.nl.
authors: Daisy
authors: D
authors: Walter
authors: Department of Gastroenterology and Hepatology, University Medical Center Utrecht, Utrecht, The Netherlands.
authors: Petra G A
authors: PG
authors: van Boeckel
authors: Department of Gastroenterology and Hepatology, Rijnstate Hospital, Arnhem, The Netherlands.
authors: Marcel J
authors: MJ
authors: Groenen
authors: Department of Gastroenterology and Hepatology, St. Antonius Hospital, Nieuwegein, The Netherlands.
authors: Bas L A M
authors: BL
authors: Weusten
authors: Department of Gastroenterology and Hepatology, Gelderse Vallei Hospital, Ede, The Netherlands.
authors: Ben J
authors: BJ
authors: Witteman
authors: Department of Gastroenterology and Hepatology, Twente Hospital, Hengelo, The Netherlands.
authors: Gi
authors: G
authors: Tan
authors: Department of Gastroenterology and Hepatology, Meander Medical Center, Amersfoort, The Netherlands.
authors: Menno A
authors: MA
authors: Brink
authors: Department of Gastroenterology and Hepatology, Haga Hospital, Den Haag, The Netherlands.
authors: Jan
authors: J
authors: Nicolai
authors: Department of Gastroenterology and Hepatology, Canisius Wilhelmina Hospital, Nijmegen, The Netherlands.
authors: Adriaan C
authors: AC
authors: Tan
authors: Department of Gastroenterology and Hepatology, Albert Schweitzer Hospital, Dordrecht, The Netherlands.
authors: Joyce
authors: J
authors: Alderliesten
authors: Department of Gastroenterology and Hepatology, Medisch Spectrum Twente, Enschede, The Netherlands.
authors: Niels G
authors: NG
authors: Venneman
authors: Department of Gastroenterology and Hepatology, University Hospital Gasthuisberg, University of Leuven, Leuven, Belgium.
authors: Wim
authors: W
authors: Laleman
authors: Department of Gastroenterology and Hepatology, Onze Lieve Vrouwe Gasthuis, Amsterdam, The Netherlands.
authors: Jeroen M
authors: JM
authors: Jansen
authors: Department of Gastroenterology and Hepatology, Amphia Hospital, Breda, The Netherlands.
authors: Alexander
authors: A
authors: Bodelier
authors: Department of Gastroenterology and Hepatology, VieCuri Hospital, Venlo, The Netherlands.
authors: Frank L
authors: FL
authors: Wolters
authors: Department of Gastroenterology and Hepatology, Martini Hospital, Groningen, The Netherlands.
authors: Laurens A
authors: LA
authors: van der Waaij
authors: Department of Gastroenterology and Hepatology, Diakonessen Hospital, Utrecht, The Netherlands.
authors: Ronald
authors: R
authors: Breumelhof
authors: Department of Gastroenterology and Hepatology, University Medical Center Groningen, Groningen, The Netherlands.
authors: Frank T M
authors: FT
authors: Peters
authors: Department of Gastroenterology and Hepatology, Jeroen Bosch Hospital, Den Bosch, The Netherlands.
authors: Robbert C H
authors: RC
authors: Scheffer
authors: Department of Gastroenterology and Hepatology, University Medical Center Utrecht, Utrecht, The Netherlands.
authors: Max
authors: M
authors: Leenders
authors: Department of Gastroenterology and Hepatology, University Medical Center Utrecht, Utrecht, The Netherlands.
authors: Meike M C
authors: MM
authors: Hirdes
authors: Department of Decision Analysis, Erasmus University Medical Center, Rotterdam, The Netherlands.
authors: Ewout W
authors: EW
authors: Steyerberg
authors: Department of Gastroenterology and Hepatology, University Medical Center Utrecht, Utrecht, The Netherlands.
authors: Frank P
authors: FP
authors: Vleggaar
authors: Department of Gastroenterology and Hepatology, University Medical Center Utrecht, Utrecht, The Netherlands.
authors: Peter D
authors: PD
authors: Siersema
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D017734:Bile Ducts, Extrahepatic / Q000473:pathology*; D002760:Cholangiopancreatography, Endoscopic Retrograde; D001651:Cholestasis, Extrahepatic / Q000473:pathology / Q000601:surgery*; D003362:Cost-Benefit Analysis; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008670:Metals; D008875:Middle Aged; D010166:Palliative Care / Q000379:methods*; D015607:Stents; D016896:Treatment Outcome
chemical_list: D008670:Metals
keywords: Cost Comparison; ERCP; Pancreatic Cancer; Randomized Trial