Efficacy and safety of covered self-expandable metal stents for management of distal malignant biliary obstruction due to lymph node metastases.

Background: Distal malignant biliary obstruction (MBO) due to lymph node metastases (LNM) is a common problem in advanced malignant disease. However, the role of covered self-expandable metal stents (SEMS) in treating MBO has not been studied. The aim of this study was to evaluate the efficacy and safety of covered SEMS for the treatment of distal MBO due to LNM.
Methods: Between November 1994 and December 2009, a total of 65 patients with distal MBO due to LNM underwent covered (n = 44) and uncovered (n = 21) SEMS placement.
Results: Successful drainage was achieved in all patients. There was no significant difference in patient survival. The cumulative stent patency of covered SEMS was significantly higher than that of uncovered SEMS (P = 0.0020). Stent occlusion occurred in 5 patients (11%) with covered SEMS and in 8 (38%) with uncovered SEMS. There was no tumor ingrowth in covered SEMS, but seven in the uncovered SEMS group showed some ingrowth. Cholecystitis was not observed, but mild pancreatitis was observed in 6 (14%) of those with covered SEMS. No stent-insertion-related deaths occurred.
Conclusions: Covered SEMS are safe and effective for treatment of distal malignant biliary obstruction due to LNM.