title: Randomized multicenter study of multiple plastic stents vs. covered self-expandable metallic stent in the treatment of biliary stricture in chronic pancreatitis.
abstract: OBJECTIVE
  The use of covered self-expandable metallic stents (cSEMS) in benign biliary indications is evolving. The aim of the study was to assess the safety and feasibility of cSEMS compared with multiple plastic stents in the treatment of benign biliary stricture (BBS) caused by chronic pancreatitis.
  
  
  METHODS
  This was a prospective, multicenter, randomized study of 60 patients with BBS caused by chronic pancreatitis. All patients received an initial plastic stent before randomization. At randomization, the stent was replaced either with a single cSEMS or three plastic stents. After 3 months, the position of the cSEMS was checked or another three plastic stents were added. At 6 months after randomization, all stents were removed. Clinical follow-up including abdominal ultrasound and laboratory tests were performed at 6 months and 2 years after stent removal.
  
  
  RESULTS
  Two patients dropped out of the cSEMS group before stent removal. In April 2014, the median follow-up was 40 months (range 1 - 66 months). The 2-year, stricture-free success rate was 90 % (95 % confidence interval [CI] 72 % - 97 %) in the plastic stent group and 92 % (95 %CI 70 % - 98 %) in the cSEMS group (P = 0.405). There was one late recurrence in the plastic stent group 50 months after stent removal. Stent migration occurred three times (10 %) in the plastic stent group and twice in the cSEMS group (7 %; P = 1.000).
  
  
  CONCLUSIONS
  A 6-month treatment with either six 10-Fr plastic stents or with one 10-mm cSEMS produced good long-term relief of biliary stricture caused by chronic pancreatitis.Study registered at ClinicalTrials.gov (NCT01085747).
authors.affiliation: Department of Gastrointestinal Surgery, Helsinki University Central Hospital, Helsinki, Finland.
authors.forename: Carola
authors.initials: C
authors.lastname: Haapamäki
authors.affiliation: Department of Gastrointestinal Surgery, Helsinki University Central Hospital, Helsinki, Finland.
authors.forename: Leena
authors.initials: L
authors.lastname: Kylänpää
authors.affiliation: Department of Gastrointestinal Surgery, Helsinki University Central Hospital, Helsinki, Finland.
authors.forename: Marianne
authors.initials: M
authors.lastname: Udd
authors.affiliation: Department of Gastrointestinal Surgery, Helsinki University Central Hospital, Helsinki, Finland.
authors.forename: Outi
authors.initials: O
authors.lastname: Lindström
authors.affiliation: Department of Digestive Surgery, Turku University Hospital, Turku, Finland.
authors.forename: Juha
authors.initials: J
authors.lastname: Grönroos
authors.affiliation: Department of Gastrointestinal Surgery, Oulu University Hospital, Oulu, Finland.
authors.forename: Arto
authors.initials: A
authors.lastname: Saarela
authors.affiliation: Department of Gastrointestinal Surgery, Helsinki University Central Hospital, Helsinki, Finland.
authors.forename: Harri
authors.initials: H
authors.lastname: Mustonen
authors.affiliation: Department of Gastrointestinal Surgery, Helsinki University Central Hospital, Helsinki, Finland.
authors.forename: Jorma
authors.initials: J
authors.lastname: Halttunen
mesh_terms: D000328:Adult; D000368:Aged; D002760:Cholangiopancreatography, Endoscopic Retrograde; D001651:Cholestasis, Extrahepatic / Q000209:etiology / Q000628:therapy*; D003131:Combined Modality Therapy; D003137:Common Bile Duct Diseases / Q000209:etiology / Q000628:therapy*; D003251:Constriction, Pathologic / Q000209:etiology / Q000628:therapy; D005240:Feasibility Studies; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D050500:Pancreatitis, Chronic / Q000150:complications*; D011446:Prospective Studies; D000069322:Self Expandable Metallic Stents; D016717:Sphincterotomy, Endoscopic; D015607:Stents; D016896:Treatment Outcome