We wanted to determine the technical and clinical efficacy of placing a self-expandable PTFE-covered nitinol stent for the management of inoperable malignant biliary obstruction.

Thirty six patients with inoperable malignant biliary obstructions were treated by placement of self-expandable PTFE-covered nitinol stents (S & G Biotech Corporation, Seongnam, Korea). Clinical evaluation was done with assessment of the serum bilirubin and alkaline phosphatase levels, which were measured before and after stent placement within 1 week, at 1 month and at 3 months. The patient survival rate and stent patency rate were calculated with performing Kaplan-Meier survival analysis.

Successful stent placement was achieved in all the patients without procedure-related complication. Pancreatitis as an early complication occurred in two cases. The serum bilirubin and alkaline phosphatase levels were significantly decreased after the procedure. During the follow-up, recurrent obstructive jaundice occurred in six cases; stent migration occurred in four cases and tumor overgrowth occurred in two cases. The survival rates were 97%, 80%, 67% and 59% at 1, 3, 6 and 9 months, respectively. The stent patency rates were 96%, 92%, 86% and 86% at 1, 3, 6 and 9 months, respectively.

Self-expandable PTFE-covered nitinol stent placement seems to be technically feasible and effective for the palliative treatment of malignant biliary obstruction.