title: Antireflux Versus Conventional Plastic Stent in Malignant Biliary Obstruction: A Prospective Randomized Study.
abstract: OBJECTIVE
  Endoscopic stents are used to relieve obstructive jaundice. The purpose of this prospective randomized study was to compare the patency of antireflux and conventional plastic biliary stent in relieving distal malignant biliary obstruction.
  
  
  METHODS
  All jaundiced patients admitted to hospital with suspected unresectable malignant distal biliary stricture between October 2009 and September 2010 were evaluated for the study. Eligible patients were randomized either to antireflux or conventional plastic stent arms. The primary endpoint was stent patency and the follow-up was continued either until the stent was occluded or until 6 months after the stent placement.
  
  
  RESULTS
  At an interim analysis, antireflux stents (ARSs; n = 6) had a significantly shorter median patency of 34 (8-49) days compared with the conventional stent (n = 7) patency of 167 (38-214) days (P = .0003). Based on these results, the study was terminated due to ethical concerns.
  
  
  CONCLUSIONS
  According to these results, the use of this ARS is not recommended.
authors.affiliation: 1 Department of Digestive Surgery, Turku University Hospital, Turku University , Turku, Finland .
authors.forename: Hanna
authors.initials: H
authors.lastname: Vihervaara
authors.affiliation: 1 Department of Digestive Surgery, Turku University Hospital, Turku University , Turku, Finland .
authors.forename: Juha M
authors.initials: JM
authors.lastname: Grönroos
authors.affiliation: 2 Department of Biostatistics, University of Turku , Turku, Finland .
authors.forename: Saija
authors.initials: S
authors.lastname: Hurme
authors.affiliation: 1 Department of Digestive Surgery, Turku University Hospital, Turku University , Turku, Finland .
authors.forename: Risto
authors.initials: R
authors.lastname: Gullichsen
authors.affiliation: 1 Department of Digestive Surgery, Turku University Hospital, Turku University , Turku, Finland .
authors.forename: Paulina
authors.initials: P
authors.lastname: Salminen
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002779:Cholestasis / Q000209:etiology / Q000628:therapy*; D057239:Early Termination of Clinical Trials; D005260:Female; D006801:Humans; D041781:Jaundice, Obstructive / Q000209:etiology; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000150:complications*; D010969:Plastics; D011446:Prospective Studies; D011475:Prosthesis Failure; D015607:Stents / Q000009:adverse effects; D013997:Time Factors
chemical_list: D010969:Plastics
keywords: ERCP; antireflux stent; distal biliary obstruction; plastic stent; stent patency