title: Prospective multicenter trial of esophageal Z-stent placement for malignant dysphagia and tracheoesophageal fistula.
abstract: BACKGROUND
  Conventional esophageal prosthesis placement has been associated with a 6% to 8% perforation rate and numerous postplacement complications. Expandable esophageal stents have been developed to preclude the above but there are few studies that have prospectively defined clinical results and subsequent stent-related complications.
  
  
  METHODS
  All patients who underwent esophageal Z-stent placement at nine university or referral hospitals were prospectively assessed. Data collected included patient demographics, acute and subacute placement problems, the ability to occlude airway fistulas, prestent and poststent dysphagia scores, and patient survival.
  
  
  RESULTS
  Fifty-four of 56 patients (96%) with refractory dysphagia or malignant esophagoairway fistulae had 73 Z-stents successfully inserted. Initial distal deployment occurred in 13% of the patients and an additional 17% required balloon dilation to achieve maximal diameter. Acute placement complications occurred in 11% of patients and included severe pain (3), bleeding from necrotic tumor (2), and hiatal hernia intussusception (1). No perforations occurred. Eight of 11 patients (73%) had complete tracheoesophageal fistula occlusion and mean dysphagia score (+/- SD) improved from 2.6 (0.7) to 1.1 (1.2) (p < 0.01). Fifteen stents (27%) had delayed migration at a mean of 1 month and 3 required surgery for retrieval. Three patients had ultimate stent erosion resulting in bleeding in 2 (exsanguination 1) or fistula (treated with a conventional stent).
  
  
  CONCLUSIONS
  The authors conclude that esophageal Z-stents can be placed safely and successfully in the majority of patients. The tendency of distal deployment during placement and subsequent migration problems at a time distant from placement in a patient subset deserve attention and are currently being addressed.
authors.affiliation: Virginia Mason Medical Center, Seattle, Washington 98101, USA.
authors.forename: R A
authors.initials: RA
authors.lastname: Kozarek
authors.forename: S
authors.initials: S
authors.lastname: Raltz
authors.forename: W R
authors.initials: WR
authors.lastname: Brugge
authors.forename: R H
authors.initials: RH
authors.lastname: Schapiro
authors.forename: I
authors.initials: I
authors.lastname: Waxman
authors.forename: H W
authors.initials: HW
authors.lastname: Boyce
authors.forename: J
authors.initials: J
authors.lastname: Baillie
authors.forename: M S
authors.initials: MS
authors.lastname: Branch
authors.forename: P D
authors.initials: PD
authors.lastname: Stevens
authors.forename: C J
authors.initials: CJ
authors.lastname: Lightdale
authors.forename: G A
authors.initials: GA
authors.lastname: Lehman
authors.forename: S
authors.initials: S
authors.lastname: Benjamin
authors.forename: D E
authors.initials: DE
authors.lastname: Fleischer
authors.forename: A
authors.initials: A
authors.lastname: Axelrad
authors.forename: P
authors.initials: P
authors.lastname: Kortan
authors.forename: N
authors.initials: N
authors.lastname: Marcon
authors.forename: S
authors.initials: S
authors.lastname: Branch
authors.forename: P
authors.initials: P
authors.lastname: Stevens
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002404:Catheterization; D003680:Deglutition Disorders / Q000209:etiology / Q000628:therapy*; D004947:Esophagus; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D015337:Multicenter Studies as Topic; D009369:Neoplasms / Q000150:complications*; D011446:Prospective Studies; D015607:Stents / Q000009:adverse effects; D014138:Tracheoesophageal Fistula / Q000628:therapy*; D016896:Treatment Outcome