title: A new partially covered nitinol stent for palliative treatment of malignant bile duct obstruction: a multicenter single-arm prospective study.
abstract: OBJECTIVE
  Covered self-expanding metal stents (SEMSs) have proven effective for managing malignant bile duct strictures and may reduce risk of tumor ingrowth. A new nitinol partially covered biliary SEMS was prospectively evaluated.
  
  
  METHODS
  70 patients with inoperable extrahepatic biliary obstructions were enrolled in a prospective multicenter trial, and followed up to 6 months or death, whichever came first. Primary endpoint was adequate palliation defined as absence of recurrent biliary obstruction from partly covered SEMS placement to end of follow-up.
  
  
  RESULTS
  Mean age of the patients was 69 years and 52 % were men. Pancreatic carcinoma was present in 68 %. One stent was placed in 67 patients, two patients received two, and in one patient a guide wire could not traverse the stricture. In 55 % of patients the SEMS was inserted de novo and in 45 % for exchange with a plastic stent. Technical success was 97 %. At 6 months, 62 % of patients were free of obstructive symptoms; compared with baseline the mean number of symptoms per patient was significantly reduced (3.1 at baseline, 0.6 at 6 months; P < 0.0001) and total bilirubin levels dropped by 73 %. There were four cases of recurrent biliary obstruction, due to stent migration (2), tumor overgrowth (1), and sludge formation (1). Device-related complications included cholecystitis (3), right upper quadrant pain (1), and moderate pancreatitis (1). No tumor ingrowth was reported.
  
  
  CONCLUSIONS
  This new partially covered nitinol SEMS is easily inserted, and safe and effective in the palliation of biliary obstruction secondary to malignant bile duct strictures.
authors.affiliation: Università Cattolica del Sacro Cuore, Rome, Italy. gcostamagna@rm.unicatt.it
authors.forename: G
authors.initials: G
authors.lastname: Costamagna
authors.forename: A
authors.initials: A
authors.lastname: Tringali
authors.forename: D N
authors.initials: DN
authors.lastname: Reddy
authors.forename: J
authors.initials: J
authors.lastname: Devière
authors.forename: M
authors.initials: M
authors.lastname: Bruno
authors.forename: T
authors.initials: T
authors.lastname: Ponchon
authors.forename: H
authors.initials: H
authors.lastname: Neuhaus
authors.forename: M
authors.initials: M
authors.lastname: Mutignani
authors.forename: G V
authors.initials: GV
authors.lastname: Rao
authors.forename: S
authors.initials: S
authors.lastname: Lakhtakia
authors.forename: O
authors.initials: O
authors.lastname: Le Moine
authors.forename: P
authors.initials: P
authors.lastname: Fockens
authors.forename: E A
authors.initials: EA
authors.lastname: Rauws
authors.forename: V
authors.initials: V
authors.lastname: Lepilliez
authors.forename: B
authors.initials: B
authors.lastname: Schumacher
authors.forename: A
authors.initials: A
authors.lastname: Seelhoff
authors.forename: D
authors.initials: D
authors.lastname: Carr-Locke
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000497:Alloys; D001650:Bile Duct Neoplasms / Q000150:complications* / Q000556:secondary; D001651:Cholestasis, Extrahepatic / Q000209:etiology / Q000601:surgery*; D020099:Coated Materials, Biocompatible; D003137:Common Bile Duct Diseases / Q000209:etiology / Q000601:surgery; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010166:Palliative Care; D015607:Stents / Q000009:adverse effects
chemical_list: D000497:Alloys; D020099:Coated Materials, Biocompatible; C013616:nitinol