title: Self-expandable metal stents for relieving malignant colorectal obstruction: short-term safety and efficacy within 30 days of stent procedure in 447 patients.
abstract: BACKGROUND
  The self-expandable metal stent (SEMS) can alleviate malignant colonic obstruction and avoid emergency decompressive surgery.
  
  
  OBJECTIVE
  To document performance, safety, and effectiveness of colorectal stents used per local standards of practice in patients with malignant large-bowel obstruction to avoid palliative stoma surgery in incurable patients (PAL) and facilitate bowel decompression as a bridge to surgery for curable patients (BTS).
  
  
  METHODS
  Prospective clinical cohort study.
  
  
  METHODS
  Two global registries with 39 academic and community centers.
  
  
  METHODS
  This study involved 447 patients with malignant colonic obstruction who received stents (255 PAL, 182 BTS, 10 no indication specified).
  
  
  METHODS
  Colorectal through-the-scope SEMS placement.
  
  
  METHODS
  The primary endpoint was clinical success at 30 days, defined as the patient's ability to maintain bowel function without adverse events related to the procedure or stent. Secondary endpoints were procedural success, defined as successful stent placement in the correct position, symptoms of persistent or recurrent colonic obstruction, and complications.
  
  
  RESULTS
  The procedural success rate was 94.8% (439/463), and the clinical success rates were 90.5% (313/346) as assessed on a per protocol basis and 71.6% (313/437) as assessed on an intent-to-treat basis. Complications included 15 (3.9%) perforations, 3 resulting in death, 7 (1.8%) migrations, 7 (1.8%) cases of pain, and 2 (0.5%) cases of bleeding.
  
  
  CONCLUSIONS
  No control group. No primary endpoint analysis data for 25% of patients.
  
  
  CONCLUSIONS
  This largest multicenter, prospective study of colonic SEMS placement demonstrates that colonic SEMSs are safe and highly effective for the short-term treatment of malignant colorectal obstruction, allowing most curable patients to have 1-step resection without stoma and providing most incurable patients minimally invasive palliation instead of surgery. The risk of complications, including perforation, was low.
authors.affiliation: Bispebjerg Hospital, Copenhagen, Denmark.
authors.forename: Søren
authors.initials: S
authors.lastname: Meisner
authors.forename: Ferran
authors.initials: F
authors.lastname: González-Huix
authors.forename: Jo G
authors.initials: JG
authors.lastname: Vandervoort
authors.forename: Paul
authors.initials: P
authors.lastname: Goldberg
authors.forename: Juan A
authors.initials: JA
authors.lastname: Casellas
authors.forename: Oscar
authors.initials: O
authors.lastname: Roncero
authors.forename: Karl E
authors.initials: KE
authors.lastname: Grund
authors.forename: Alberto
authors.initials: A
authors.lastname: Alvarez
authors.forename: Jesús
authors.initials: J
authors.lastname: García-Cano
authors.forename: Enrique
authors.initials: E
authors.lastname: Vázquez-Astray
authors.forename: Javier
authors.initials: J
authors.lastname: Jiménez-Pérez
mesh_terms: D000368:Aged; D003113:Colonoscopy; D015179:Colorectal Neoplasms / Q000150:complications* / Q000601:surgery; D005260:Female; D006801:Humans; D007415:Intestinal Obstruction / Q000209:etiology / Q000628:therapy*; D007416:Intestinal Perforation / Q000209:etiology; D008297:Male; D010166:Palliative Care; D015607:Stents / Q000009:adverse effects