Self-expanding metal stents were implanted in 30 patients (14 men and 16 women, mean age 67 [40-86] years) with malignant (n = 27) or benign (n = 3) obstruction of the biliary tract (hepatic duct bifurcation: n = 14; choledochal duct: n = 16). The stents were introduced and left in place endoscopically in 13, percutaneously and transhepatically via a 7 or 9 F catheter in 17 patients. The stents, which expand to a diameter of 7-10 mm, in all cases achieved complete drainage, as confirmed by cholangiography. Jaundice completely disappeared in 28 of 30 patients. No complications were noted during a 30-day period of observation. After a median follow-up period of 90 days, 17 patients have been without jaundice for a median period of 141 (30-330) days. A recurrence of jaundice was noted in three patients (restenosis proximal to the stent in 2, incrustation with bile in one). Ten patients died, without any signs pointing to stent occlusion. These data indicate that the probability of stent patency in malignant stenoses of 200 days after implantation is 84%, so that stents in most cases provide a safe and effective means of drainage. Because they have a relatively large lumen with small surface area infection, occlusion and migration apparently occur less often than with conventional synthetic prostheses.