Prospective, randomized, single-center trial comparing 3 different 10F plastic stents in malignant mid and distal bile duct strictures

Background: The aim of this study was to determine whether patency rates differ with respect to the material, design, and surface texture of 3 different plastic stents. Methods: A total of 120 patients (median age 70.5 years; interquartile range 62-78 years) with malignant mid or distal bile duct strictures, seen between March 1996 and May 1999, were prospectively randomized to receive a 10F polyurethane stent, a Teflon Tannenbaum stent, or a hydrophilic hydromer-coated polyurethane stent. The primary study outcome measure was the interval between stent insertion and the first episode of clogging (or the presence of jaundice at death without stent exchange). All 3 types of stent were studied by scanning electron microscopy before insertion. Results: A total of 19 patients were excluded from long-term follow-up. Median duration of stent patency was 76 days overall (interquartile range 29-150 days) and 76 (interquartile range 30-110) days for hydrophilic hydromer-coated polyurethane, 108 (interquartile range 33-186) days for 10F polyurethane, and 58 (interquartile range 21-188) days for Teflon Tannenbaum stents. There were no statistically significant differences among stent types. The hydrophilic hydromer-coated stent had the smoothest surface, as visualized by scanning electron microscopy. Conclusions: No significant differences in the patency of 3 types of stents were detected in this randomized trial. In particular, the hydrophilic hydromer-coated plastic stent did not provide clinical advantages despite its smooth surface.