title: Placement of a triple-layered covered versus uncovered metallic stent for palliation of malignant gastric outlet obstruction: a multicenter randomized trial.
abstract: BACKGROUND
  Usually, uncovered self-expandable metallic stents (SEMS) are used for palliation of malignant gastric outlet obstruction (GOO). A triple-layered covered SEMS is reported to be efficacious, but its performance has not been compared with uncovered SEMS. The present study is the first to compare the efficacy and safety of a triple-layered covered versus uncovered SEMS.
  
  
  METHODS
  A multicenter randomized study was conducted in two tertiary referral centers, with 62 eligible patients with symptomatic GOO to receive covered (n = 31) or uncovered SEMS (n = 31). The primary endpoint was SEMS patency, and secondary endpoints were success rate and adverse events after complete follow up.
  
  
  RESULTS
  Both groups had a technical success rate of 100% and comparable clinical success rates (P = 0.67). There was nostatistically significant difference in stent patency and adverse events between the two groups (P = 0.52 and P = 0.38, respectively). Although the occurrence rate of persistent obstructive symptoms was comparable (P = 0.42), that of recurrent obstructive symptoms was higher in the uncovered group (29% vs 3.6%, P = 0.0125). Patient survival did not differ between groups (P = 0.34).
  
  
  CONCLUSIONS
  There was no statistically significant difference in stent patency, but use of a triple-layered covered SEMS was associated with less frequent stent dysfunction more than 4 weeks after stenting, despite similar short-term outcomes.
authors.affiliation: Division of Gastroenterology and Hepatology, Department of Internal Medicine, Toho University Ohashi Medical Center.
authors.forename: Iruru
authors.initials: I
authors.lastname: Maetani
authors.forename: Yoshinori
authors.initials: Y
authors.lastname: Mizumoto
authors.forename: Hiroaki
authors.initials: H
authors.lastname: Shigoka
authors.forename: Shigefumi
authors.initials: S
authors.lastname: Omuta
authors.forename: Michihiro
authors.initials: M
authors.lastname: Saito
authors.forename: Junya
authors.initials: J
authors.lastname: Tokuhisa
authors.forename: Toshio
authors.initials: T
authors.lastname: Morizane
mesh_terms: D000368:Aged; D020099:Coated Materials, Biocompatible; D005260:Female; D005500:Follow-Up Studies; D017219:Gastric Outlet Obstruction / Q000175:diagnosis / Q000209:etiology / Q000601:surgery*; D005773:Gastroscopy / Q000379:methods*; D006801:Humans; D008297:Male; D010166:Palliative Care / Q000379:methods*; D011446:Prospective Studies; D011474:Prosthesis Design; D015607:Stents; D013274:Stomach Neoplasms / Q000150:complications* / Q000175:diagnosis / Q000601:surgery; D016896:Treatment Outcome
chemical_list: D020099:Coated Materials, Biocompatible
keywords: covered stent; gastric outlet obstruction (GOO); self-expandable metallic stent (SEMS); uncovered stent