Daisy Walter1, Petra G A van Boeckel2, Marcel J Groenen3, Bas L A M Weusten4, Ben J Witteman5, Gi Tan6, Menno A Brink7, Jan Nicolai8, Adriaan C Tan9, Joyce Alderliesten10, Niels G Venneman11, Wim Laleman12, Jeroen M Jansen13, Alexander Bodelier14, Frank L Wolters15, Laurens A van der Waaij16, Ronald Breumelhof17, Frank T M Peters18, Robbert C H Scheffer19, Max Leenders2, Meike M C Hirdes2, Ewout W Steyerberg20, Frank P Vleggaar2, Peter D Siersema2. 1. Department of Gastroenterology and Hepatology, University Medical Center Utrecht, Utrecht, The Netherlands. Electronic address: d.walter@umcutrecht.nl. 2. Department of Gastroenterology and Hepatology, University Medical Center Utrecht, Utrecht, The Netherlands. 3. Department of Gastroenterology and Hepatology, Rijnstate Hospital, Arnhem, The Netherlands. 4. Department of Gastroenterology and Hepatology, St. Antonius Hospital, Nieuwegein, The Netherlands. 5. Department of Gastroenterology and Hepatology, Gelderse Vallei Hospital, Ede, The Netherlands. 6. Department of Gastroenterology and Hepatology, Twente Hospital, Hengelo, The Netherlands. 7. Department of Gastroenterology and Hepatology, Meander Medical Center, Amersfoort, The Netherlands. 8. Department of Gastroenterology and Hepatology, Haga Hospital, Den Haag, The Netherlands. 9. Department of Gastroenterology and Hepatology, Canisius Wilhelmina Hospital, Nijmegen, The Netherlands. 10. Department of Gastroenterology and Hepatology, Albert Schweitzer Hospital, Dordrecht, The Netherlands. 11. Department of Gastroenterology and Hepatology, Medisch Spectrum Twente, Enschede, The Netherlands. 12. Department of Gastroenterology and Hepatology, University Hospital Gasthuisberg, University of Leuven, Leuven, Belgium. 13. Department of Gastroenterology and Hepatology, Onze Lieve Vrouwe Gasthuis, Amsterdam, The Netherlands. 14. Department of Gastroenterology and Hepatology, Amphia Hospital, Breda, The Netherlands. 15. Department of Gastroenterology and Hepatology, VieCuri Hospital, Venlo, The Netherlands. 16. Department of Gastroenterology and Hepatology, Martini Hospital, Groningen, The Netherlands. 17. Department of Gastroenterology and Hepatology, Diakonessen Hospital, Utrecht, The Netherlands. 18. Department of Gastroenterology and Hepatology, University Medical Center Groningen, Groningen, The Netherlands. 19. Department of Gastroenterology and Hepatology, Jeroen Bosch Hospital, Den Bosch, The Netherlands. 20. Department of Decision Analysis, Erasmus University Medical Center, Rotterdam, The Netherlands.
Abstract
BACKGROUND & AIMS: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.
RCT Entities:
BACKGROUND & AIMS: 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.
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