Efficacy of a novel self-expandable metal stent with dumbbell-shaped flare ends for distal biliary obstruction due to unresectable pancreatic cancer

This study aimed to evaluate the efficacy of a novel fully covered self-expandable metal stent (SEMS) with dumbbell-shaped flare ends for the palliation of distal biliary obstruction (DBO) due to unresectable pancreatic cancer (UPC). Patients with DBO due to UPC who received the novel HILZO fully covered stent (HFS), the WALLFLEX partially covered stent (WPS) or fully covered stent (WFS) were analyzed. The incidence of recurrent biliary obstruction (RBO), time to RBO (TRBO), and the incidence of complications were compared among the three SEMS groups. Eighty-four patients (HFS, n=36; WPS, n=20; WFS, n=28) were included. The incidence of RBO was low in the HFS group (versus the WPS and WFS group, p=0.033 and 0.023, respectively). TRBO in the HFS group was longer than that in the WFS group (p=0.049). Placement of the HFS was an independent factor for long TRBO in multivariable analysis (p=0.040). The incidence of pancreatitis and cholecystitis in the HFS group was low (one for each). It is recommended to use the HFS for the palliation of DBO due to UPC from the viewpoint of the low incidence of RBO and complications.

Automated summary

The study evaluated the efficacy of a novel fully covered self-expandable metal stent (SEMS) for the palliation of distal biliary obstruction (DBO) caused by unresectable pancreatic cancer (UPC). The results showed that the incidence of recurrent biliary obstruction (RBO) was lower and the time to RBO (TRBO) was longer in the HFS group compared to the other two groups. Additionally, the incidence of complications was lower in the HFS group. Therefore, the use of HFS stent is recommended for the palliation of DBO due to UPC.