title: Ultraflex precision colonic stent placement for palliation of malignant colonic obstruction: a prospective multicenter study.
abstract: BACKGROUND
  Many patients who develop obstructive colonic symptoms secondary to inoperable colorectal cancer will require palliative treatment. A minimally invasive and potentially long-lasting approach is placement of nitinol self-expanding metal stents (SEMS).
  
  
  OBJECTIVE
  To determine the effectiveness and safety of a nitinol SEMS designed for colorectal use in the palliative treatment of malignant colonic obstruction.
  
  
  METHODS
  Prospective multicenter clinical study.
  
  
  METHODS
  Nine European study centers.
  
  
  METHODS
  Forty-four patients with malignant colonic obstruction.
  
  
  METHODS
  Placement of nitinol SEMS designed for colorectal use.
  
  
  METHODS
  Technical success, defined as accurate SEMS deployment with adequate stricture coverage, and clinical success, defined as decompression and relief of obstructive colonic symptoms maintained without intervention or serious device-related complications.
  
  
  RESULTS
  Technical success was attained in 95% of patients, with 95% CI 85%-99%. After 6 months, the rate of clinical success was 81%, 95% CI 69%-96%. Survival at 6 months was 67%, 95% CI 54%-84%. Clinical success was maintained until death in 86% of the nonsurvivors. No perforations or SEMS-related deaths occurred.
  
  
  CONCLUSIONS
  This investigation was nonrandomized and did not include a control group.
  
  
  CONCLUSIONS
  In a large prospective investigation, palliative placement of a nitinol SEMS designed for colorectal use was accomplished with a high rate of technical success. Durable clinical success was achieved in a high proportion of patients with low morbidity.
authors: Servizio di Endoscopia Digestiva, IRCCS Istituto Clinico Humanitas, Milano, Italy.
authors: Alessandro
authors: A
authors: Repici
authors: Diego
authors: D
authors: Fregonese
authors: Guido
authors: G
authors: Costamagna
authors: Remi
authors: R
authors: Dumas
authors: Georg
authors: G
authors: Kähler
authors: Søren
authors: S
authors: Meisner
authors: Marc
authors: M
authors: Giovannini
authors: Jan
authors: J
authors: Freeman
authors: Lucio
authors: L
authors: Petruziello
authors: Cristina
authors: C
authors: Hervoso
authors: Salvatore
authors: S
authors: Comunale
authors: Roger
authors: R
authors: Faroux
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000497:Alloys; D003106:Colon / Q000601:surgery; D003110:Colonic Neoplasms / Q000150:complications / Q000601:surgery; D005260:Female; D006801:Humans; D007415:Intestinal Obstruction / Q000601:surgery*; D008297:Male; D010166:Palliative Care; D011446:Prospective Studies; D019919:Prosthesis Implantation / Q000379:methods*; D015607:Stents; D015996:Survival Rate
chemical_list: D000497:Alloys; C013616:nitinol