A multicenter prospective study of the short-term outcome of a newly developed partially covered self-expandable metallic biliary stent (WallFlex(®))

Dig Dis Sci. 2011 Jun;56(6):1889-95. doi: 10.1007/s10620-011-1581-6. Epub 2011 Feb 6.

Abstract

Background: Self-expandable metallic stent (SEMS) placement is a widely used, effective therapy for unresectable malignant stricture of the lower bile duct.

Aims: We evaluated the short-term outcome of the newly developed WallFlex(®) Biliary RX Partially Covered Stent in patients with malignant lower and middle biliary stricture in five tertiary referral centers.

Methods: The subjects of this study were 52 patients in whom WallFlex(®) Biliary RX Stents were inserted into the bile duct for malignant stenosis of the middle and lower bile duct at five medical facilities between April 2009 and November 2009.

Results: The stent placement success rate was 100%. Effective biliary decompression was achieved in all patients. The incidence of early complications was 7.7% (4/52). Stent occlusion occurred in two patients (3.8%) (one dislocation, one migration); cholecystitis occurred in two patients (3.8%). Neither acute pancreatitis nor stent kinking in the bile duct occurred.

Conclusions: The present results revealed that the new WallFlex(®) Biliary RX Partially Covered SEMSs were useful for the short-term relief of biliary obstruction due to unresectable distal biliary malignancies.

Publication types

  • Clinical Trial
  • Multicenter Study

MeSH terms

  • Aged
  • Aged, 80 and over
  • Cholestasis / etiology
  • Cholestasis / surgery*
  • Constriction, Pathologic / surgery
  • Female
  • Gastrointestinal Neoplasms / complications
  • Humans
  • Male
  • Middle Aged
  • Stents*