title: The Clinical Outcome in Patients Treated With a Newly Designed SEMS in Cervical Esophageal Strictures and Fistulas.
abstract: OBJECTIVE
  Using a self-expandable metallic stent (SEMS) in the cervical esophagus is controversial due to an increased risk of complications. Here we assessed a new type of SEMS purpose-designed for the cervical esophagus area.
  
  
  METHODS
  Patients with malignant or benign stenosis within 4 cm distance of the upper esophageal sphincter who underwent placement of a SEMS with a shorter proximal head (Niti-S Esophageal Covered Stent-Cervical-type, NSECSC), were included. Main outcome measures were the functional outcome, tolerance, complications, recurrent dysphagia, and survival.
  
  
  RESULTS
  About 37 patients had an NSECSC placed between April 2008 and June 2013 for esophageal stenosis (malignant=20, benign=17), 5 with associated tracheoesophageal fistula. The mean stenosis-upper esophageal sphincter distance was 1.86±1.27 cm. The median follow-up was 150 days. Dysphagia improved in 27/37 cases (73%). Short-term and long-term tolerance without needing stent removal was 92% and 82%, respectively. The complication rate was 59% (22/37): 32% (n=14) major complications [fistula (3), perforation (3), aspiration pneumonia (5), laryngeal dyspnea (2), and bleeding (1)], and 27% (n=10) minor complications [pain (7) or dysphonia (3)]. A multivariate analysis confirmed a higher risk of major complications in cases of benign stenosis (odds ratio=5.2; 95% confidence interval, 1.05-25.90; P=0.04). Recurrent dysphagia occurred in 15 patients (obstruction=7, migration=8).
  
  
  CONCLUSIONS
  The NSECSC does not appear less morbid than standard SEMS in the cervical esophageal area, but could be useful in malignant indications as it is well-tolerated and offers effective palliation of the dysphagia. However, this device should not be used in benign cervical esophageal strictures or fistulas.
authors.affiliation: *Digestive Diseases Department §Clinical Research Unit, NHE University Hospital †Auvergne University/Research Unit CNRS 6284 ISIT (Image Sciences for Innovations Techniques) ‡Biostatistics Unit, DRCI, Gabriel Montpied University Hospital, Clermont-Ferrand, France.
authors.forename: Laurent
authors.initials: L
authors.lastname: Poincloux
authors.forename: Camille
authors.initials: C
authors.lastname: Sautel
authors.forename: Olivier
authors.initials: O
authors.lastname: Rouquette
authors.forename: Bruno
authors.initials: B
authors.lastname: Pereira
authors.forename: Marion
authors.initials: M
authors.lastname: Goutte
authors.forename: Gilles
authors.initials: G
authors.lastname: Bommelaer
authors.forename: Michel
authors.initials: M
authors.lastname: Dapoigny
authors.forename: Armand
authors.initials: A
authors.lastname: Abergel
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D003680:Deglutition Disorders / Q000209:etiology; D004937:Esophageal Fistula / Q000473:pathology / Q000601:surgery*; D004938:Esophageal Neoplasms / Q000473:pathology / Q000601:surgery*; D004940:Esophageal Stenosis / Q000473:pathology / Q000601:surgery*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D011474:Prosthesis Design; D012189:Retrospective Studies; D015607:Stents; D014138:Tracheoesophageal Fistula / Q000473:pathology / Q000601:surgery; D016896:Treatment Outcome