title: A fully covered self-expandable metal stent with antimigration features for benign biliary strictures: a prospective, multicenter cohort study.
abstract: BACKGROUND
  Self-expandable metal stents (SEMSs) are increasingly used for the treatment of benign biliary strictures (BBSs). A new fully covered SEMS (FCSEMS) with flared ends and high conformability was designed to prevent migration of the stent.
  
  
  OBJECTIVE
  To evaluate the efficacy of a novel FCSEMS with antimigration features.
  
  
  METHODS
  Prospective cohort study.
  
  
  METHODS
  Five hospitals in the Netherlands and Belgium.
  
  
  METHODS
  Consecutive patients with BBS.
  
  
  METHODS
  FCSEMS placement for 3 months.
  
  
  METHODS
  Initial and long term clinical success, stent migration rate and safety.
  
  
  RESULTS
  Thirty-eight patients (24 men; mean age, 53 ± 16 years) were included. Stent placement was technically successful in 37 patients (97%). Two patients died of an unrelated cause before stent removal, and no data on these patients were available on stricture resolution. Initial clinical success was achieved in 28 of 35 patients (80%). During follow-up after stent removal, a symptomatic recurrent stricture developed in 6 of 28 patients (21%). Overall, the long-term clinical success rate was 63% (22 of 35 patients). Stent migration occurred in 11 of 35 patients (31%), including 5 symptomatic (14%) and 6 asymptomatic (17%) migrations. In total, 11 serious adverse events occurred in 10 patients (29%), with cholangitis (n = 5) being most common.
  
  
  CONCLUSIONS
  Nonrandomized study design.
  
  
  CONCLUSIONS
  Good initial clinical success was achieved after placement of this novel FCSEMS, but stricture recurrence was in the upper range compared with other FCSEMSs. The antimigration design could not prevent migration in a significant number of patients with a persisting stricture.
authors: Gastroenterology and Hepatology, University Medical Center Utrecht, Utrecht, the Netherlands.
authors: Daisy
authors: D
authors: Walter
authors: Liver and Biliopancreatic Disorders, University Hospital Gasthuisberg, KU Leuven, Leuven, Belgium.
authors: Wim
authors: W
authors: Laleman
authors: Gastroenterology and Hepatology, Onze Lieve Vrouwe Gasthuis, Amsterdam, the Netherlands.
authors: Jeroen M
authors: JM
authors: Jansen
authors: Gastroenterology and Hepatology, Amphia Hospital, Breda, the Netherlands.
authors: A W M
authors: AW
authors: van Milligen de Wit
authors: Gastroenterology and Hepatology, St. Antonius Hospital, Nieuwegein, the Netherlands.
authors: Bas L
authors: BL
authors: Weusten
authors: Gastroenterology and Hepatology, University Medical Center Utrecht, Utrecht, the Netherlands.
authors: Petra G
authors: PG
authors: van Boeckel
authors: Gastroenterology and Hepatology, University Medical Center Utrecht, Utrecht, the Netherlands.
authors: Meike M
authors: MM
authors: Hirdes
authors: Gastroenterology and Hepatology, University Medical Center Utrecht, Utrecht, the Netherlands.
authors: Frank P
authors: FP
authors: Vleggaar
authors: Gastroenterology and Hepatology, University Medical Center Utrecht, Utrecht, the Netherlands.
authors: Peter D
authors: PD
authors: Siersema
mesh_terms: D000328:Adult; D000368:Aged; D002760:Cholangiopancreatography, Endoscopic Retrograde; D002779:Cholestasis / Q000628:therapy*; D003251:Constriction, Pathologic; D020878:Device Removal; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D000069322:Self Expandable Metallic Stents