title: Wing-shaped plastic stents vs. self-expandable metal stents for palliative drainage of malignant distal biliary obstruction: a randomized multicenter study.
abstract: OBJECTIVE
  Previous studies have shown superior patency rates for self-expandable metal stents (SEMS) compared with plastic stents in patients with malignant biliary obstruction. The aim of this study was to compare stent patency, patient survival, and complication rates between a newly designed, wing-shaped, plastic stent and SEMSs in patients with unresectable, malignant, distal, biliary obstruction.
  
  
  METHODS
  A randomized, multicenter trial was conducted at four tertiary care centers in Germany. A total of 37 patients underwent randomization between March 2010 and January 2013. Patients underwent endoscopic retrograde cholangiography with insertion of either a wing-shaped, plastic stent without lumen or an SEMS.
  
  
  RESULTS
  Stent failure occurred in 10/16 patients (62.5 %) in the winged-stent group vs. 4/18 patients (22.2 %) in the SEMS group (P = 0.034). The median time to stent failure was 51 days (range 2 - 92 days) for the winged stent and 80 days (range 28 - 266 days) for the SEMS (P = 0.002). Early stent failure (< 8 weeks after placement) occurred in 8 patients (50 %) vs. 2 patients (11.1 %), respectively (P = 0.022). After obtaining the results from this interim analysis, the study was discontinued because of safety concerns.
  
  
  CONCLUSIONS
  The frequency of stent failure was significantly higher in the winged-stent group compared with the SEMS group. A high incidence of early stent failure within 8 weeks was observed in the winged-stent group. Thus, the winged, plastic stent without central lumen may not be appropriate for mid or long term drainage of malignant biliary obstruction. Study registration ClinicalTrials.gov (NCT01063634).
authors.affiliation: Department of Gastroenterology and Oncology, Klinikum Ludwigsburg, Ludwigsburg, Germany.
authors.forename: Arthur
authors.initials: A
authors.lastname: Schmidt
authors.affiliation: Department of Gastroenterology and Oncology, Klinikum Ludwigsburg, Ludwigsburg, Germany.
authors.forename: Bettina
authors.initials: B
authors.lastname: Riecken
authors.affiliation: Department of Gastroenterology and Oncology, Klinikum Ludwigsburg, Ludwigsburg, Germany.
authors.forename: Susanne
authors.initials: S
authors.lastname: Rische
authors.affiliation: Department of Gastroenterology and Oncology, Klinikum Ludwigsburg, Ludwigsburg, Germany.
authors.forename: Christoph
authors.initials: C
authors.lastname: Klinger
authors.affiliation: Department of Gastroenterology, Klinikum Ludwigshafen, Ludwigshafen, Germany.
authors.forename: Ralf
authors.initials: R
authors.lastname: Jakobs
authors.affiliation: Department of Gastroenterology, Klinikum Ludwigshafen, Ludwigshafen, Germany.
authors.forename: Matthias
authors.initials: M
authors.lastname: Bechtler
authors.affiliation: Department of Surgery, University Medical Center Mannheim, University of Heidelberg, Mannheim, Germany.
authors.forename: Georg
authors.initials: G
authors.lastname: Kähler
authors.affiliation: Department of Medicine, Cologne City Hospital, Holweide, Cologne, Germany.
authors.forename: Arno
authors.initials: A
authors.lastname: Dormann
authors.affiliation: Department of Gastroenterology and Oncology, Klinikum Ludwigsburg, Ludwigsburg, Germany.
authors.forename: Karel
authors.initials: K
authors.lastname: Caca
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002760:Cholangiopancreatography, Endoscopic Retrograde; D002780:Cholestasis, Intrahepatic / Q000209:etiology / Q000628:therapy*; D004067:Digestive System Neoplasms / Q000150:complications*; D004322:Drainage / Q000295:instrumentation*; D057239:Early Termination of Clinical Trials; D004867:Equipment Design; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010166:Palliative Care; D010969:Plastics / Q000009:adverse effects; D011475:Prosthesis Failure / Q000209:etiology*; D000069322:Self Expandable Metallic Stents / Q000009:adverse effects; D015996:Survival Rate; D013997:Time Factors
chemical_list: D010969:Plastics