PURPOSE: To compare the clinical efficacy and treatment costs of plast
ic versus metal biliary stents. MATERIALS AND METHODS: In a randomized
trial, 101 patients with malignant common bile duct obstruction under
went transhepatic stent implantation and were followed up until death.
Patients were stratified into risk and nonrisk groups. Forty-nine pat
ients received 12-F plastic stents, and 52 received expandable metal s
tents. Plastic endoprotheses were placed in a two-step procedure; meta
l stents, in a single procedure. Kaplan-Meier analyses were used to co
mpare patient survival and stent patency rates. RESULTS: The 30-day mo
rtality rate was significantly lower for metal stents (five of 52 [10%
]) than plastic stents (12 of 49 [24%]; P=.05). The obstruction rate w
as 19% (10 of 52; median patency, 272 days) for metal stents and 27% f
or plastic stents (13 of 49; median patency, 96 days; P <.01). Median
time until death or obstruction was longer for metal stents (122 vs 81
days; P <.01). Placement of metal stents was associated with shorter
hospital stay (10 vs 21 days; P <.01) and lower cost ($7,542 vs $12,12
9; P<.01). CONCLUSION: Use of self-expanding metal stents appears to s
how substantial benefits for patients and to be cost-effective.