Self-expandable nitinol stent for the management of biliary obstruction: long-term clinical results.

PURPOSE: Technical characteristics and clinical efficacy of a new metallic stent for the management of biliary obstruction were investigated in a clinical study. PATIENTS AND METHODS: From February 1991 to January 1993, 35 self-expandable, nickel-titanium alloy wire-mesh stents (diameter, 10 mm; length, 6 cm) were placed in 19 patients with obstructive jaundice due to cholangiocarcinoma (n = 6), pancreatic carcinoma (n = 5), lymph node metastasis to the liver hilum (n = 5), gallbladder carcinoma (n = 2), and intraductal papillary mucosal hyperplasia (n = 1). RESULTS: Stent placement was successful in 18 of 19 patients. In one patient, stent dislodgment occurred after correct release; no other procedure-related complications or deaths occurred within 30 days following the procedure. Two (11%) of the remaining 18 patients are alive st 11 months; 16 (89%) died after a mean survival of 7.4 months. Two of three patients with stent obstruction underwent repeated intervention. Adequate palliation from jaundice was achieved without further intervention in 83% of cases. The mean stent patency was not less than 7 months. CONCLUSION: Use of these metallic stents reestablished bile flow in the occluded biliary tree. Their efficacy and patency rate were also adequate.