Abstract

The aim of this study was to evaluate the efficacy and safety of endoscopic bilateral biliary metal stent placement for hilar malignant obstruction. Twenty patients with unresectable malignant hilar biliary obstruction who had undergone endoscopic bilateral Y-configured biliary drainage with metal stents were enrolled as a study group (YMS group). Thirty-seven patients who had undergone bilateral drainage with plastic stents were selected as a historical control (PS group). Two newly designed metal stents for bilateral Y-configured placement were endoscopically deployed in a partial stent-in-stent manner in one session. Technical success, early complications, and stent patency were evaluated. The technical success rate in the YMS group was 100%. Mild post-endoscopic retrograde cholangiopancreatography pancreatitis occurred in one patient in the YMS group and in two in the PS group. The success rate of biliary decompression was 95% in the YMS group and 89% in the PS group (P=0.65). During a median follow-up period of 7.3months, the incidence of stent occlusion in the YMS group was significantly lower than that in the PS group (30% vs 62%, P=0.028). Mean stent patency in the YMS group was 250days and that in the PS group was 115days (P=0.0061). Risk factors for stent occlusion were bile duct cancer (P=0.035) and the PS group (P=0.07) by multivariate analysis. Single-session endoscopic bilateral biliary placement of newly designed metal stents for hilar malignant obstruction is safe and useful with a high technical success rate and a long patency period.

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