title: Cost-effectiveness and clinical efficacy of biliary stents in patients undergoing neoadjuvant therapy for pancreatic adenocarcinoma in a randomized controlled trial.
abstract: OBJECTIVE
  The optimal type of stent for the palliation of malignant biliary obstruction in patients with pancreatic adenocarcinoma undergoing neoadjuvant chemoradiotherapy with curative intent is unknown. We performed a prospective trial comparing 3 types of biliary stents-fully covered self-expandable metal (fcSEMS), uncovered self-expandable metal (uSEMS), and plastic-to determine which best optimized cost-effectiveness and important clinical outcomes.
  
  
  METHODS
  In this prospective randomized trial, consecutive patients with malignant biliary obstruction from newly diagnosed pancreatic adenocarcinoma who were to start neoadjuvant chemoradiotherapy were randomized to receive fcSEMSs, uSEMSs, or plastic stents during the index ERCP. The primary outcomes were time to stent occlusion, attempted surgical resection, or death after the initiation of neoadjuvant therapy, and the secondary outcomes were total patient costs associated with the stent, including the index ERCP cost, downstream hospitalization cost due to stent occlusion, and the cost associated with procedural adverse event.
  
  
  RESULTS
  Fifty-four patients were randomized and reached the primary end point: 16 in the fcSEMS group, 17 in the uSEMS group, and 21 in the plastic stent group. No baseline demographic or tumor characteristic differences were noted among the groups. The fcSEMSs had a longer time to stent occlusion compared with uSEMSs and plastic stents (220 vs 74 and 76 days, P < .01), although the groups had equivalent rates of stent occlusion, attempted surgical resection, and death. Although SEMS placement cost more during the index ERCP (uSEMS = $24,874 and fcSEMS = $22,729 vs plastic = $18,701; P < .01), they resulted in higher procedural AE costs per patient (uSEMS = $5522 and fcSEMS = $12,701 vs plastic = $0; P < .01). Conversely, plastic stents resulted in an $11,458 hospitalization cost per patient due to stent occlusion compared with $2301 for uSEMSs and $0 for fcSEMSs (P < .01).
  
  
  CONCLUSIONS
  In a prospective trial comparing fcSEMSs, uSEMSs, and plastic stents for malignant biliary obstruction in patients undergoing neoadjuvant therapy with curative intent for pancreatic adenocarcinoma, no stent type was superior in optimizing cost-effectiveness, although fcSEMSs resulted in fewer days of neoadjuvant treatment delay and a longer time to stent occlusion. (Clincial trial registration number: NCT01038713.).
authors.affiliation: Section of Gastroenterology and Hepatology, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, USA.
authors.forename: Timothy B
authors.initials: TB
authors.lastname: Gardner
authors.affiliation: Section of Gastroenterology and Hepatology, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, USA.
authors.forename: Chad C
authors.initials: CC
authors.lastname: Spangler
authors.affiliation: Section of Gastroenterology and Hepatology, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, USA.
authors.forename: Katerina L
authors.initials: KL
authors.lastname: Byanova
authors.affiliation: Section of Hematology and Oncology, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, USA.
authors.forename: Gregory H
authors.initials: GH
authors.lastname: Ripple
authors.affiliation: Section of Gastroenterology and Hepatology, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, USA.
authors.forename: Matthew J
authors.initials: MJ
authors.lastname: Rockacy
authors.affiliation: Section of Gastroenterology and Hepatology, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, USA.
authors.forename: John M
authors.initials: JM
authors.lastname: Levenick
authors.affiliation: Section of General Surgery, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, USA.
authors.forename: Kerrington D
authors.initials: KD
authors.lastname: Smith
authors.affiliation: Section of General Surgery, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, USA.
authors.forename: Thomas A
authors.initials: TA
authors.lastname: Colacchio
authors.affiliation: Section of General Surgery, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, USA.
authors.forename: Richard J
authors.initials: RJ
authors.lastname: Barth
authors.affiliation: Division of Radiation Oncology, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, USA.
authors.forename: Bassem I
authors.initials: BI
authors.lastname: Zaki
authors.affiliation: Division of Radiology, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, USA.
authors.forename: Michael J
authors.initials: MJ
authors.lastname: Tsapakos
authors.affiliation: Section of Gastroenterology and Hepatology, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, USA.
authors.forename: Stuart R
authors.initials: SR
authors.lastname: Gordon
mesh_terms: D000230:Adenocarcinoma / Q000150:complications / Q000628:therapy*; D000368:Aged; D059248:Chemoradiotherapy; D002760:Cholangiopancreatography, Endoscopic Retrograde / Q000191:economics / Q000295:instrumentation; D002779:Cholestasis / Q000209:etiology / Q000601:surgery*; D003362:Cost-Benefit Analysis; D005260:Female; D006801:Humans; D008297:Male; D008670:Metals / Q000191:economics; D008875:Middle Aged; D020360:Neoadjuvant Therapy; D010190:Pancreatic Neoplasms / Q000150:complications / Q000628:therapy*; D010969:Plastics / Q000191:economics; D000069322:Self Expandable Metallic Stents / Q000191:economics; D015607:Stents / Q000191:economics; D016896:Treatment Outcome; D014481:United States
chemical_list: D008670:Metals; D010969:Plastics