title: Esophageal stents with antireflux valve for tumors of the distal esophagus and gastric cardia: a randomized trial.
abstract: BACKGROUND
  Self-expandable metal stents deployed across the gastroesophageal junction predispose to gastroesophageal reflux. The efficacy of a stent with an antireflux mechanism in preventing gastroesophageal reflux was assessed.
  
  
  METHODS
  Thirty patients with carcinoma of the distal esophagus or of the gastric cardia were randomized to receive either a stent with a windsock-type antireflux valve (FerX-Ella) (n = 15) or a standard open stent (n = 15) of the same design minus the valve. Gastroesophageal reflux was assessed by using standardized questionnaires and by 24-hour pH monitoring 14 days after treatment.
  
  
  RESULTS
  Technical problems occurred during stent placement in 3 patients: migration (n = 2) and a problem with the introducing system (n = 1). Dysphagia improved from a median score of 3 (liquids only) to 1 (eat some solid food) in the antireflux group and from 3 to 0 (solid foods) in the open stent group ( p > 0.20). Reflux symptoms were reported by 3/12 patients (25%) with an antireflux stent and by 2/14 (14%) with an open stent. In 11 patients, 24-hour pH monitoring was obtained, and increased esophageal acid exposure (normal: <4%) was present with both types of stent: median 24-hour reflux time (9 patients) with the antireflux stent was 23% vs. 10% in (2 patients) with the open stent ( p = NS). Major complications occurred in 3 patients (20%) in each group and included bleeding (n = 3), severe pain (n = 2), and aspiration pneumonia (n = 1). The main cause of recurrent dysphagia was stent migration, which occurred in 7 of the 30 patients (23%).
  
  
  CONCLUSIONS
  The FerX-Ella antireflux stent provided relief of dysphagia caused by malignancy of the distal esophagus and gastric cardia. However, the antireflux valve failed to prevent gastroesophageal reflux.
authors.affiliation: Department of Gastroenterology, Erasmus MC University Medical Center, Rotterdam, The Netherlands.
authors.forename: Marjolein Y V
authors.initials: MY
authors.lastname: Homs
authors.forename: Peter J
authors.initials: PJ
authors.lastname: Wahab
authors.forename: Ernst J
authors.initials: EJ
authors.lastname: Kuipers
authors.forename: Ewout W
authors.initials: EW
authors.lastname: Steyerberg
authors.forename: Tim A
authors.initials: TA
authors.lastname: Grool
authors.forename: Jelle
authors.initials: J
authors.lastname: Haringsma
authors.forename: Peter D
authors.initials: PD
authors.lastname: Siersema
mesh_terms: D000368:Aged; D002299:Cardia; D003680:Deglutition Disorders / Q000209:etiology / Q000628:therapy; D004938:Esophageal Neoplasms / Q000150:complications / Q000628:therapy*; D005260:Female; D005764:Gastroesophageal Reflux / Q000517:prevention & control; D006801:Humans; D008297:Male; D011475:Prosthesis Failure; D012008:Recurrence; D015607:Stents