title: A new metal stent with a controlled-release system for palliation of malignant dysphagia: a prospective, multicenter study.
abstract: BACKGROUND
  Self-expanding metal stents are frequently used for the palliation of malignant dysphagia. Recently, a new stent design, the Evolution stent (Cook Medical, Limerick, Ireland), was developed. The stent has an internal and external silicone coating to resist tissue ingrowth and uncoated dual flanges on both ends to prevent migration. Its controlled-release system may allow full control and precise positioning of the stent.
  
  
  OBJECTIVE
  To determine the safety and clinical effectiveness of the Evolution stent for the palliation of dysphagia in patients with malignant strictures located in the esophagus (n = 33 [75%]) or gastric cardia (n = 11 [25%]).
  
  
  METHODS
  All patients who underwent placement of an esophageal Evolution stent from February to December 2008 received follow-up telephone calls 14 days after treatment and thereafter monthly until death. Data on technical and clinical outcome, complications, and recurrent dysphagia were collected.
  
  
  RESULTS
  A total of 44 patients (32 [73%] men, median age 74 years [range 48-91 years]) were treated with the Evolution stent. The median tumor length was 6 cm (range 1-11 cm). Stent placement was technically successful in 41 patients. Dysphagia improved from a median of 3 (ability to swallow liquids only) to 1 (ability to eat some solid foods) 4 weeks after stent placement. Major complications occurred in 4 (9%) patients, ie, pneumonia (3 patients) and hemorrhage (1 patient). Two (5%) patients died of pneumonia. Minor complications included gastroesophageal reflux and mild retrosternal pain in 11 (25%) and 4 (9%) patients, respectively. Recurrent dysphagia developed in 11 (25%) patients as a result of tissue ingrowth or overgrowth (6 patients; 14%), food impaction (3 patients; 7%), or stent migration (2 patients; 5%).
  
  
  CONCLUSIONS
  The Evolution stent is safe and effective for the palliation of dysphagia from esophageal and gastric cardia cancer. Randomized trials are needed to compare this device with other stent designs.
authors.affiliation: Department of Gastroenterology and Hepatology, University Medical Center Utrecht, Utrecht, The Netherlands.
authors.forename: Petra G A
authors.initials: PG
authors.lastname: van Boeckel
authors.forename: Alessandro
authors.initials: A
authors.lastname: Repici
authors.forename: Frank P
authors.initials: FP
authors.lastname: Vleggaar
authors.forename: Biagio
authors.initials: B
authors.lastname: Solito
authors.forename: Giacomo
authors.initials: G
authors.lastname: Rando
authors.forename: Claudio
authors.initials: C
authors.lastname: Cortelezzi
authors.forename: Mauro
authors.initials: M
authors.lastname: Rossi
authors.forename: Nico
authors.initials: N
authors.lastname: Pagano
authors.forename: Alberto
authors.initials: A
authors.lastname: Malesci
authors.forename: Peter D
authors.initials: PD
authors.lastname: Siersema
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D002299:Cardia; D003680:Deglutition Disorders / Q000209:etiology / Q000628:therapy*; D004938:Esophageal Neoplasms / Q000150:complications; D004940:Esophageal Stenosis / Q000209:etiology; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010166:Palliative Care; D011183:Postoperative Complications / Q000453:epidemiology; D011446:Prospective Studies; D011474:Prosthesis Design; D012008:Recurrence; D015607:Stents / Q000009:adverse effects; D013274:Stomach Neoplasms / Q000150:complications