Abstract:Objective: To investigate the efficacy and safety of fully covered self-expandable metal stents (FCSEMS) and plastic stents (PS) placement in the treatment of malignant obstructive jaundice by endoscopic retrograde cholangiopancreatography (ERCP). Methods: From November, 2012 to December, 2018, a total of 92 patients with unresectable malignant distal biliary obstruction underwent ERCP with placement of FCSEMS (WallFlex; Boston Scientific) and PS for the palliation of obstructive jaundice. Data were retrospectively analyzed for the following variables: patient survival, duration of stent patency, the need for subsequent biliary intervention, and complications. Results: The technical success rate of ERCP operation was 100% in FCSEMS and PS group, The clinical success rate was statistically lower with PS group (94.2% vs 75.0%, P<0.01). The bilirubin levels of both groups were significantly decreased after ERCP (P<0.01). The survival time was similar with FCSEMS and PS group (6.5 months vs.7.2months,P>0.05). The FCSEMS group had a significantly longer patency time compared to PS group (182.0d vs. 84.0d, P<0.01). There was also no statistically significant difference in complication after ERCP. The stent occlusion rate was significantly higher in the PS group than in the FCSEMS group (7.8% vs. 25.0%,P<0.05). The mean number of reinterventions was significantly lower in the FCSEMS group than in the PS group (0.06 vs. 0.38,P< 0.01). There was no significant difference in total cost between the two groups (PS vs. FCSEMS ¥42956.1 vs. ¥44851.5, t = 1.84, P = 0.07). Conclusion: The fully covered WallFlex stent had higher patency rate compared with PS. FCSEMS was a safe, effective and inexpensive treatment for unresectable malignant distal biliary obstruction.