title: Prospective evaluation of the partially covered nitinol "ComVi" stent for malignant non hilar biliary obstruction.
abstract: BACKGROUND
  Biliary partially covered self-expandable metal stents (PC-SEMS) offer prolonged relief of symptoms of biliary obstruction but may induce complications including pancreatitis, cholecystitis and migration.
  
  
  OBJECTIVE
  To assess efficacy and safety of the ComVi partially covered self-expandable metal stents as primary palliative treatment of distal malignant biliary obstruction.
  
  
  METHODS
  Seventy patients (mean age 69.2 years) with distal malignant biliary strictures were prospectively included and underwent endoscopic retrograde cholangio-pancreatography and partially covered self-expandable metal stents placement. Follow-up was done for 12 months. self-expandable metal stents patency, survival and complication-rate after partially covered self-expandable metal stents placement were evaluated.
  
  
  RESULTS
  Overall median survival time was 190 days (30-856). Forty-four patients (62.8%) died after median 175.5 days (30-614) without signs of stent dysfunction; 37 patients (52.8%) were alive after 6 months without signs of self-expandable metal stents occlusion. Survival rapidly dropped between 8 and 12 months after treatment. Survival was not influenced by sex (P = 0.1) or type of neoplasia (P = 0.178). Median survival was longer (254 days [44-836]) in patients who underwent chemotherapy (P < 0.0001). Partially covered self-expandable metal stents occlusion had 24 (35.7%) patients 154 days (35-485) after treatment. Median survival after re-treatment was 66 days (13-597). Cholecystitis occurred in one patient (1.7%).
  
  
  CONCLUSIONS
  The ComVi partially covered self-expandable metal stents is effective for palliation of biliary obstruction secondary to distal malignant biliary strictures. Self-expandable metal stents patency during follow-up is satisfactory without significant complications.
authors.affiliation: Digestive Endoscopy Unit, Gemelli University Hospital, Università Cattolica del Sacro Cuore, Rome, Italy.
authors.forename: Vincenzo
authors.initials: V
authors.lastname: Perri
authors.forename: Ivo
authors.initials: I
authors.lastname: Boškoski
authors.forename: Andrea
authors.initials: A
authors.lastname: Tringali
authors.forename: Pietro
authors.initials: P
authors.lastname: Familiari
authors.forename: Michele
authors.initials: M
authors.lastname: Marchese
authors.forename: Dong Ki
authors.initials: DK
authors.lastname: Lee
authors.forename: Sung Il
authors.initials: SI
authors.lastname: Jang
authors.forename: Jimin
authors.initials: J
authors.lastname: Han
authors.forename: Ho Gak
authors.initials: HG
authors.lastname: Kim
authors.forename: Massimiliano
authors.initials: M
authors.lastname: Mutignani
authors.forename: Graziano
authors.initials: G
authors.lastname: Onder
authors.forename: Guido
authors.initials: G
authors.lastname: Costamagna
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000497:Alloys; D001663:Bilirubin / Q000097:blood; D002760:Cholangiopancreatography, Endoscopic Retrograde; D002779:Cholestasis / Q000097:blood / Q000209:etiology / Q000601:surgery*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D009369:Neoplasms / Q000150:complications*; D010166:Palliative Care; D016016:Proportional Hazards Models; D015607:Stents / Q000009:adverse effects
chemical_list: D000497:Alloys; C013616:nitinol; D001663:Bilirubin