Endoscopic Y-Configured Placement of Newly Designed Metal Stents in One Session for Hilar Malignant Biliary Obstruction

Abstract

Background and Aims: Although palliative endoscopic biliary drainage is widely used for malignant hilar obstruction, endoscopic bilateral placement of metal stents is considered to be demanding and difficult. The aim of this study was to evaluate the efficacy and safety of endoscopic bilateral placement of newly designed stents in a Y-configuration in one session. Setting and design: A single center, prospective feasibility study. Materials and Methods: From January 2006 to June 2008, endoscopic Y-configured biliary drainage with metal stents was performed in 19 patients (males, 7; females, 12; mean age, 75.7 +/- 11.0 years) with unresectable malignant hilar biliary obstruction (YMS group). Two newly designed metal stents with central wide-open mesh (Niti-S stent TM, TaeWoong Co. Ltd., Seoul, Korea) were used for endoscopic bilateral metal stent placement. For a Y-configuration, two stents were placed in a partial-stent-in-stent manner in one session. Thirty-seven patients (males, 21; females, 16; mean age, 74.0 +/- 8.4 years) with malignant hilar biliary obstruction who had undergone bilateral biliary drainage with plastic stents were selected as a historical control (PS group). In the YMS group, there were 12 patients with bile duct cancer, 3 with cholangiocellular carcinoma, 3 with gallbladder cancer, and 1 with metastatic lymph nodes. In the PS group, there were 18 patients with bile duct cancer, 7 with cholangiocellular carcinoma, 11 with gallbladder cancer, and 1 with metastatic lymph nodes. The patients with Bismuth type I, II, III, and IV numbered 3, 7, 6, and 3 in the YMS group and 9, 10, 12, and 6 in the PS group, respectively. Successful cases of biliary decompression were defined as those in which serum total bilirubin level (TB) became normal (0.2-1.2 mg/dL) or those whose TB decreased to less than a third of that before performance of stent placement. Results: The technical success rate in the YMS group was 100%. Mild post-ERCP pancreatitis occurred in one patient. The success rate of biliary decompression was 89% in the YMS group and 78% in the PS group (P = 0.29). During the mean follow-up period of 134 +/- 179 days, the incidence of stent occlusion in the YMS group was significantly lower than that in the PS group (32% vs. 62%, P = 0.030). Median stent patency in the YMS group and in the PS group was 239 days (95%CI, 89-322) and 99 days (95%CI, 63-135), respectively, with a statistically significant difference (P = 0.012). Conclusions: Endoscopic Y-configured placement of newly designed metal stents in one session is safe and useful with a high success rate for bilateral biliary drainage in patients with hilar malignant obstruction.