title: A prospective, randomized multicenter trial comparing DoubleLayer and polyethylene stents for malignant distal common bile duct strictures.
abstract: OBJECTIVE
  Endoscopic biliary stenting is an established treatment for malignant obstructive jaundice. Stent clogging continues to be a major problem with plastic stents. The aim of this study was to carry out a prospective comparison of two stents with different materials and shapes: the Olympus DoubleLayer stent (DLS; perfluoro alkoxy, without sideholes) and the standard polyethylene (PE) stent (with sideholes).
  
  
  METHODS
  A total of 120 patients (70 women; mean age 71, range 36 - 91) with jaundice due to malignant strictures of the middle to distal third of the common bile duct were randomly assigned to receive either DLS (n = 60) or PE (n = 60) biliary stents. Patients with cholangitis, hemobilia, previous biliary drainage, hilar stricture, or ampullary cancer were excluded.
  
  
  RESULTS
  In all, 28 DLS patients (47 %) and 17 PE stent patients (29 %) died without clinical evidence of stent occlusion after a mean of 114 and 105 days, respectively ( P < 0.05). Twenty-six DLS patients (43 %) and 38 PE stent patients (63 %) had symptoms of stent clogging after a mean of 144 and 99 days, respectively ( P < 0.05). Stent dysfunction (stent orifice impacted on the bile duct or duodenal wall, stent migration) was recorded in six DLS patients (10 %) and five PE patients (8 %) (n. s.). Kaplan-Meier analysis of DLS and PE stent clogging-free survival showed a significantly longer patency period with the DLS stents (P = 0.0005).
  
  
  CONCLUSIONS
  These results show that DoubleLayer stents have a longer patency period than PE stents. Patients who received PE stents had a higher risk of stent occlusion (relative risk 3.05; 95 % CI, 1.57 - 5.89) before death than DLS patients.
authors.affiliation: Digestive Endoscopy Unit, Catholic University, Rome, Italy.
authors.forename: A
authors.initials: A
authors.lastname: Tringali
authors.forename: M
authors.initials: M
authors.lastname: Mutignani
authors.forename: V
authors.initials: V
authors.lastname: Perri
authors.forename: G
authors.initials: G
authors.lastname: Zuccalà
authors.forename: L
authors.initials: L
authors.lastname: Cipolletta
authors.forename: M A
authors.initials: MA
authors.lastname: Bianco
authors.forename: G
authors.initials: G
authors.lastname: Rotondano
authors.forename: M
authors.initials: M
authors.lastname: Philipper
authors.forename: B
authors.initials: B
authors.lastname: Schumacher
authors.forename: H
authors.initials: H
authors.lastname: Neuhaus
authors.forename: A
authors.initials: A
authors.lastname: Schmit
authors.forename: J
authors.initials: J
authors.lastname: Devière
authors.forename: G
authors.initials: G
authors.lastname: Costamagna
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001661:Biliary Tract Neoplasms / Q000150:complications; D003135:Common Bile Duct / Q000473:pathology*; D003251:Constriction, Pathologic; D005260:Female; D006801:Humans; D041781:Jaundice, Obstructive / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D010190:Pancreatic Neoplasms / Q000150:complications; D020959:Polyethylene; D011446:Prospective Studies; D011474:Prosthesis Design; D015607:Stents
chemical_list: D020959:Polyethylene