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

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.