A Multicenter Prospective Study of the Short-Term Outcome of a Newly Developed Partially Covered Self-Expandable Metallic Biliary Stent (WallFlex®)
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Self-expandable metallic stent (SEMS) placement is a widely used, effective therapy for unresectable malignant stricture of the lower bile duct.
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.
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.
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.
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.
KeywordsCovered self-expandable metallic stents Early complications Endoscopic biliary drainage Malignant stricture of the lower bile duct Stent occlusion
The authors are indebted to Mr. Roderick J. Turner and Assistant Professor Edward Barroga of the Department of International Medical Communications at Tokyo Medical University for their review of this manuscript.
Conflict of interest
The following authors disclose financial relationships relevant to this publication: Takayoshi Tsuchiya and Takao Itoi: give lectures and serve as consultants of Boston Scientific Corp.; Takao Itoi is also a consultant of Olympus Medical Systems. The other authors disclose no financial relationships relevant to this publication.