title: A prospective, randomized study of the patency period of the plastic antireflux biliary stent: an interim analysis.
abstract: BACKGROUND
  There is as yet no ideal design of a plastic biliary stent with the longest patency period.
  
  
  OBJECTIVE
  To study the safety and effective patency period of a new plastic antireflux biliary stent in the clinical setting.
  
  
  METHODS
  We conducted a prospective, randomized trial to compare the patency of 2 similar plastic biliary stents, one of which has an antiduodenobiliary reflux property.
  
  
  METHODS
  The study was conducted at 2 separate tertiary centers in 2 countries.
  
  
  METHODS
  Patients with inoperable distal malignant biliary obstruction were recruited.
  
  
  METHODS
  One of the 2 types of plastic stents under study was randomly chosen and inserted in the common bile duct of the study subjects. The subjects were followed until the end of study or occlusion occurrence.
  
  
  METHODS
  Our primary endpoint was the time to stent occlusion in days, with stent-related adverse events and all-cause mortality the secondary endpoints.
  
  
  RESULTS
  A total of 16 subjects were recruited for the study; 7 were allocated to group A (ordinary Tannenbaum stent) and 9 to group B (antireflux biliary stent). Five of 7 subjects (71%) in group B had stent occlusion within 8 days, and the primary end point was reached in all 7 subjects within 30 days, whereas the primary endpoint was not reached within 30 days in any of the subjects in group A. Our data showed a significantly shorter stent patency period in group B compared with group A (P < .003).
  
  
  CONCLUSIONS
  Small sample size.
  
  
  CONCLUSIONS
  Routine use of antireflux plastic biliary stents in the palliative management of malignant biliary obstructions cannot be recommended at present. (Clinical trial registration number: NCT01142921.).
authors.affiliation: Tan Tock Seng Hospital, Republic of Singapore.
authors.forename: Quan Wai
authors.initials: QW
authors.lastname: Leong
authors.affiliation: Tan Tock Seng Hospital, Republic of Singapore.
authors.forename: Mira L
authors.initials: ML
authors.lastname: Shen
authors.affiliation: Institute of Digestive Disease, Prince of Wales Hospital, The Chinese University of Hong Kong, Shatin, Hong Kong SAR.
authors.forename: Kim W
authors.initials: KW
authors.lastname: Au
authors.affiliation: Institute of Digestive Disease, Prince of Wales Hospital, The Chinese University of Hong Kong, Shatin, Hong Kong SAR.
authors.forename: Derek
authors.initials: D
authors.lastname: Luo
authors.affiliation: Institute of Digestive Disease, Prince of Wales Hospital, The Chinese University of Hong Kong, Shatin, Hong Kong SAR.
authors.forename: James Y
authors.initials: JY
authors.lastname: Lau
authors.affiliation: Institute of Digestive Disease, Prince of Wales Hospital, The Chinese University of Hong Kong, Shatin, Hong Kong SAR.
authors.forename: Justin C
authors.initials: JC
authors.lastname: Wu
authors.affiliation: Institute of Digestive Disease, Prince of Wales Hospital, The Chinese University of Hong Kong, Shatin, Hong Kong SAR.
authors.forename: Francis K
authors.initials: FK
authors.lastname: Chan
authors.affiliation: Institute of Digestive Disease, Prince of Wales Hospital, The Chinese University of Hong Kong, Shatin, Hong Kong SAR.
authors.forename: Joseph J
authors.initials: JJ
authors.lastname: Sung
mesh_terms: D000328:Adult; D000368:Aged; D001652:Bile Ducts / Q000601:surgery*; D002779:Cholestasis / Q000601:surgery*; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D010166:Palliative Care / Q000379:methods*; D010969:Plastics; D011446:Prospective Studies; D011474:Prosthesis Design; D015607:Stents; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D010969:Plastics