In patients with malignant biliary obstruction, endoscopic placement of biliary stents offers similar technical success rates but a lower risk of complications and a trend towards decreased mortality when compared to surgical bypass and percutaneous drainage [1,2]. As a result, over the last three decades, endoscopic retrograde cholangiography (ERC)-guided stent placement has become the preferred approach to palliate malignant biliary obstruction.Until the 1990s, only plastic stents were available. Plastic stents may occlude within 3-6 months, often requiring repeated ERC procedures in order to exchange the stents. The introduction of a stainless-steel uncovered metal stent (Wallstent, Boston Scientific) heralded a major advance in extending the duration of stent patency. Although self-expandable metallic stents (SEMS) are more expensive than plastic stents, they are cost-effective when compared to plastic stents for patients expected to live longer than 3 months due to the need for fewer subsequent ERC procedures [1,[3][4][5][6]. Nonetheless, SEMS do eventually occlude in 19-40 % of patients [3][4][5]. The duration of SEMS patency has remained largely unchanged in spite of modifications in stent composition and the addition of a plastic coating [7][8][9]. Thus, a clear need exists for technologic improvements that minimize stent occlusion.The major mechanisms of SEMS occlusion are tumor ingrowth, tumor overgrowth, and epithelial hyperplasia. These mechanisms provide the rationale for developing a stent that is coated with or locally elutes a chemotherapeutic agent in order to improve stent patency. In vitro and animal studies suggest that a paclitaxel-coated stent may be safe and potentially efficacious when used for malignant biliary obstruction. Kalinoswki et al. [10] demonstrated that incubation with paclitaxel inhibited proliferation of human gallbladder cells, human fibroblasts, and pancreatic cells in a dose-dependent fashion. In a porcine model, SEMS coated with a paclitaxel-incorporated membrane were not associated with transmural necrosis or perforation [11]. Paclitaxel-eluting stents also appear to be safe in a canine model [12].Limited data exist regarding outcomes of paclitaxeleluting stents for malignant biliary obstruction in humans. In a pilot study of 21 humans with malignant biliary obstruction, SEMS coated with a paclitaxel-incorporated membrane remained patent for a mean of 429 days (cumulative patency rate at 3, 6, and 12 months of 100, 71, and 36 %, respectively) [13]. The pilot study suggests a paclitaxel-coated SEMS may provide longer patency rates than the 10-12 months provided by standard uncovered or covered SEMS and informed the author's decision to proceed with a larger prospective study [1].The current study by the same investigators is a prospective comparison of standard covered SEMS to SEMS covered by a paclitaxel-incorporated membrane [14]. Stents were 5-8 cm in length and 10 mm in diameter in both groups. The authors initially planned the study as a randomized controlled trial...