title: Multiple plastic stents versus covered metal stent for treatment of anastomotic biliary strictures after liver transplantation: a prospective, randomized, multicenter trial.
abstract: OBJECTIVE
  Treatment of anastomotic biliary strictures (ABSs) after orthotopic liver transplantation by endoscopic insertion of multiple plastic stents (MPSs) is well established. The use of covered self-expandable metal stents (cSEMSs) for this indication is less investigated.
  
  
  METHODS
  In an open-label, multicenter, randomized trial, patients with confirmed ABSs were randomly assigned 1:1 to receive either an MPS or a cSEMS. The primary endpoint was the number of endoscopic interventions until ABS resolution. Secondary endpoints were frequency of adverse events, treatment success rates, and time to treatment success and recurrence of ABS during follow-up of at least 1 year.
  
  
  RESULTS
  Fifty-eight patients were included between 2012 and 2015, and 48 patients completed follow-up. Patients receiving MPS (n = 24) underwent a median of 4 (range, 3-12) endoscopic retrograde cholangiography examinations, whereas those in the cSEMS group (n = 24) underwent a median of 2 (range, 2-12) sessions until ABS resolution (P < .001). A median of 8 (range, 2-32) stents was used until ABS resolution within the MPS group and 1 (range, 1-24) in the cSEMS group (P < .0001). cSEMS migration occurred in 8 (33.3%) patients. Treatment duration did not differ significantly. Initial treatment success rates were high with 23 (95.8%) in the MPS group and 24 (100%) for cSEMSs (P = 1). Five (20.8%) patients in both groups showed stricture recurrence after a median follow-up of 500 days (range, 48-1317 days).
  
  
  CONCLUSIONS
  cSEMSs for treatment of ABSs needed less endoscopic interventions to achieve similar efficacy as MPS and might become a new treatment standard. However, the optimal duration of cSEMS therapy and cost-efficacy have to be evaluated. (Clinical trial registration number: NCT01393067.).
authors.affiliation: Department of Internal Medicine I, Frankfurt University Hospital, Frankfurt, Germany.
authors.forename: Andrea Oliver
authors.initials: AO
authors.lastname: Tal
authors.affiliation: Department of Internal Medicine I, Frankfurt University Hospital, Frankfurt, Germany.
authors.forename: Fabian
authors.initials: F
authors.lastname: Finkelmeier
authors.affiliation: Institute of Biostatistics and Mathematical Modeling, Frankfurt University Hospital, Frankfurt, Germany.
authors.forename: Natalie
authors.initials: N
authors.lastname: Filmann
authors.affiliation: Department of Gastrointestinal and General Surgery, Helsinki University Central Hospital, Helsinki, Finland.
authors.forename: Leena
authors.initials: L
authors.lastname: Kylänpää
authors.affiliation: Department of Gastrointestinal and General Surgery, Helsinki University Central Hospital, Helsinki, Finland.
authors.forename: Marianne
authors.initials: M
authors.lastname: Udd
authors.affiliation: Department of Gastroenterology, IRCCS Cà Granda, Ospedale Policlinico, Milan, Italy.
authors.forename: Ilaria
authors.initials: I
authors.lastname: Parzanese
authors.affiliation: Department of Gastroenterology, IRCCS Cà Granda, Ospedale Policlinico, Milan, Italy.
authors.forename: Paolo
authors.initials: P
authors.lastname: Cantù
authors.affiliation: Department of Gastroenterology and Hepatology, Universitätsklinikum Essen, Essen, Germany.
authors.forename: Alexander
authors.initials: A
authors.lastname: Dechêne
authors.affiliation: Department of Gastroenterology and Hepatology, Universitätsklinikum Essen, Essen, Germany.
authors.forename: Volker
authors.initials: V
authors.lastname: Penndorf
authors.affiliation: Department of General and Visceral Surgery, Frankfurt University Hospital, Frankfurt, Germany.
authors.forename: Andreas
authors.initials: A
authors.lastname: Schnitzbauer
authors.affiliation: Department of Internal Medicine I, Frankfurt University Hospital, Frankfurt, Germany.
authors.forename: Mireen
authors.initials: M
authors.lastname: Friedrich-Rust
authors.affiliation: Department of Internal Medicine I, Frankfurt University Hospital, Frankfurt, Germany.
authors.forename: Stefan
authors.initials: S
authors.lastname: Zeuzem
authors.affiliation: Department of Gastroenterology, Hepatology and Endocrinology, Robert-Bosch Hospital, Stuttgart, Germany.
authors.forename: Jörg G
authors.initials: JG
authors.lastname: Albert
mesh_terms: D000328:Adult; D000368:Aged; D000714:Anastomosis, Surgical / Q000009:adverse effects; D017734:Bile Ducts, Extrahepatic / Q000601:surgery*; D002760:Cholangiopancreatography, Endoscopic Retrograde; D002779:Cholestasis / Q000209:etiology / Q000628:therapy*; D003251:Constriction, Pathologic / Q000209:etiology / Q000628:therapy; D005260:Female; D006801:Humans; D016031:Liver Transplantation / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D010969:Plastics; D011446:Prospective Studies; D011475:Prosthesis Failure; D019233:Retreatment; D000069322:Self Expandable Metallic Stents / Q000009:adverse effects; D016896:Treatment Outcome
chemical_list: D010969:Plastics