title: Randomized Trial of Small-diameter Versus Large-diameter Esophageal Stents for Palliation of Malignant Esophageal Obstruction.
abstract: OBJECTIVE
  To assess the effect of esophageal stent diameter on outcomes of patients with malignant esophageal obstruction.
  
  
  BACKGROUND
  Esophageal self-expandable metal stents (SEMS) effectively palliate dysphagia due to malignancy, but the best stent diameter is unknown.
  
  
  METHODS
  A prospective randomized trial was conducted at a regional referral hospital. One hundred persons with unresectable esophageal cancer were enrolled, randomized to receive a SEMS of either 18 or 23 mm shaft diameter but identical design, and followed until death. Outcome measurements were dysphagia score, adverse events, endoscopic reintervention, and survival.
  
  
  RESULTS
  The study arms were evenly matched. Dysphagia resolved after stent placement in 95% in both groups. After 6 months the cumulative incidence of recurrent dysphagia was 38% (95% CI 18%-53%) versus 47% (26%-63%) in the small-diameter versus large-diameter groups, respectively (P=0.23). The cumulative incidence of adverse events was 57% in both groups at 6 months, with trends toward more frequent gastrointestinal bleeding and esophago-respiratory fistula in the large-diameter group, and more frequent stent migration, stent occlusion, and endoscopic reintervention in the small-diameter group. There was a trend toward longer survival in the small-diameter group (median survival, 5.9 vs. 3 mo; P=0.10). Higher initial performance status score and female gender were associated with improved survival. Limitations include enrollment of only 100 (of a planned 200) persons and incomplete follow-up of some participants.
  
  
  CONCLUSIONS
  Small-diameter and large-diameter esophageal SEMS provided similar palliation of dysphagia due to esophageal cancer. The overall incidence of adverse events was not affected by stent diameter, but there was a trend toward longer survival with small-diameter stents (Clinical trial registration number: NCT01894763).
authors.affiliation: *Departments of Surgery and Internal Medicine, Tenwek Hospital, Bomet, Kenya †Department of Biomedical Statistics and Informatics ‡Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, MN.
authors.forename: Russell E
authors.initials: RE
authors.lastname: White
authors.forename: Robert
authors.initials: R
authors.lastname: Chepkwony
authors.forename: Michael
authors.initials: M
authors.lastname: Mwachiro
authors.forename: Stephen L
authors.initials: SL
authors.lastname: Burgert
authors.forename: Felicity T
authors.initials: FT
authors.lastname: Enders
authors.forename: Mark
authors.initials: M
authors.lastname: Topazian
mesh_terms: D000328:Adult; D000368:Aged; D003680:Deglutition Disorders / Q000453:epidemiology / Q000209:etiology / Q000601:surgery; D016099:Endoscopy, Gastrointestinal / Q000379:methods; D004867:Equipment Design; D004938:Esophageal Neoplasms / Q000150:complications / Q000473:pathology / Q000601:surgery*; D004940:Esophageal Stenosis / Q000209:etiology / Q000473:pathology / Q000601:surgery*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D010166:Palliative Care / Q000379:methods*; D011446:Prospective Studies; D015607:Stents / Q000009:adverse effects; D015996:Survival Rate; D016896:Treatment Outcome