Abstract
BACKGROUND AND OBJECTIVES: During EUS-guided hepaticogastrostomy (EUS-HGS), bile leak usually occurs in the interval between tract dilation and stent deployment. Recently, a novel partially covered self-expandable metal stent (PCSEMS) with fine gauge stent delivery system (5.9Fr) has become available. Therefore, the aim of this prospective study was to evaluate the technical feasibility of EUS-HGS using this novel stent without tract dilation and compare it with EUS-HGS with tract dilation. METHOD: Patients with biliary disease who required EUS-BD were eligible for enrollment in this study. The primary outcome was the technical success rate of stent deployment without tract dilation. RESULTS: The technical success rate of the one-step technique was 92.0% (23/25). Mean procedure time was 10.1 min, and the clinical success rate was 96% (24/25). As adverse events, bile peritonitis and stent migration were observed in one patient each. As historical controls, 75 patients who underwent EUS-HGS were enrolled in this study. As adverse events, bile peritonitis was observed in eight patients and cholangitis in three patients. After propensity score matching analysis, procedure time was significantly shorter in the one-step group compared with the two-step group (9.84 vs. 19.0 min, P < 0.001). In addition, bile peritonitis as an adverse event was significantly more frequent in the two-step group than the one-step group (P = 0.018). CONCLUSIONS: In conclusion, EUS-HGS using this novel PCSEMS might be feasible and safe, and performance of tract dilation might influence the occurrence of bile peritonitis.