The purpose of this study was to compare the clinical effectiveness of expanded
polytetrafluoroethylene/
fluorinated-ethylene-propylene (ePTFE/
FEP)-covered
stents with that of uncovered
nitinol stents for the palliation of malignant
jaundice caused by inoperable pancreatic
head cancer. Eighty patients were enrolled in a prospective randomized study. Bare
nitinol stents were used in half of the patients, and ePTFE/
FEP-covered
stents were used in the remaining patients. Patency, survival, complications, and mean cost were calculated in both groups. Mean patency was 166.0 ± 13.11 days for the bare-
stent group and 234.0 ± 20.87 days for the covered-
stent group (p = 0.007). Primary patency rates at 3, 6, and 12 months were 77.5, 69.8, and 69.8% for the bare-
stent group and 97.5, 92.2, and 87.6% for the covered-
stent group, respectively. Mean secondary patency was 123.7 ± 22.5 days for the bare-
stent group and 130.3 ± 21.4 days for the covered-
stent group. Tumour ingrowth occurred exclusively in the bare-
stent group in 27.5% of cases (p = 0.002). Median survival was 203.2 ± 11.8 days for the bare-
stent group and 247.0 ± 20 days for the covered-
stent group (p = 0.06). Complications and mean cost were similar in both groups. Regarding primary patency and ingrowth rate, ePTFE/
FEP-covered
stents have shown to be significantly superior to bare
nitinol stents for the palliation of malignant
jaundice caused by inoperable pancreatic
head cancer and pose comparable cost and complications. Use of a covered
stent does not significantly influence overall survival rate; nevertheless, the covered
endoprosthesis seems to offer result in fewer reinterventions and better quality of patient life.