Objective: To evaluate the treatment of malignant biliary stenoses and occlusions using a new stent.
Methods: In a prospective study, 25 patients with malignant obstructive jaundice were treated with SMART(R) stents. The handling and the quality of stent expansion were documented. Stent function was assessed 2 - 4 days after intervention by cholangiography and laboratory tests. A follow-up was performed three months, after stent placement.
Results: All lesions were treated successfully, with a total of 35 stents implanted. In 14 patients a further balloon dilatation was performed after stent placement (8 - 10 mm diameter/ 40 - 80 mm length). The mean serum bilirubin level decreased significantly from 11.6 mg/dl to 4.6 mg/dl after intervention (p < 0.05). The follow-up showed a mean serum bilirubin level at 4.0 mg/dl. In 4 cases (16 %) a further intervention (PTCD or stent) was performed. Six patients died due to tumor progression. The stents proved to be patent in 79 % (n = 15) of patients alive at the time of follow-up.
Conclusions: Placement of the SMART stent for the therapy of malignant biliary lesions yields good technical and clinical results.