Comparative performance of uncoated, self-expanding metal biliary stents of different designs in 2 diameters: final results of an international multicenter, randomized, controlled trial.

摘要: Background The Wallstent has remained the industry standard for biliary self-expanding metal stents (SEMSs). Recently, of differing designs, compositions, and diameters have been developed. Objective To compare new nitinol 6-mm 10-mm Zilver with stainless steel determine mechanism obstruction. Design Randomized, prospective, controlled study. Setting Nine centers experienced in SEMS placement during ERCP. Patients A total 241 patients presenting between September 2003 December 2005 unresectable malignant strictures at least 2 cm distal to bifurcation. Main Outcome Measurement Stent occlusions requiring reintervention death. Results At interim analysis, a significant increase was noted group P = .04 level, resulting arm closure but continued follow-up. Final study arms were 64, 88, 89 receiving Zilver, Wallstent, respectively. occurred 25 (39.1%) arm, 21 (23.9%) 19 (21.4%) ( .02). mean number days stent patency 142.9, 185.8, 186.7, respectively .057). No differences secondary endpoints, ended 95% censored endpoints. Biopsy specimens ingrowth occlusive tissue revealed that 56% caused by benign epithelial hyperplasia. Conclusions much more frequent diameter equivalent two despite major design, material, expansion, suggesting is critical feature. Malignant tumor produced only minority documented occlusions.