Abstract
ABSTRACT
Objectives
This study aimed to evaluate the clinical characteristics of laser‐cut self‐expandable metal stents (SEMS) and to compare the outcomes between covered and uncovered laser‐cut SEMS for malignant distal biliary obstruction (MDBO).
Methods
A multicenter retrospective analysis was conducted across eight Japanese university hospitals, including 124 patients (81 with covered and 43 with uncovered SEMS). Treatment outcomes, recurrent biliary obstruction (RBO), survival, and treatment‐related adverse events (tAEs) were compared.
Results
The rates of technical success (100% vs. 100%) and clinical success (94% vs. 98%) were comparable between the two groups. However, the incidence of RBO was significantly higher in the uncovered SEMS group compared to the covered SEMS group (37% vs. 20%,
p
= 0.034), particularly due to stent occlusion (37% vs. 14%,
p
= 0.005). Nevertheless, there were no significant differences in time to RBO (567 days vs. 459 days) or overall patient survival (277 days vs. 227 days) between the groups. The overall rate of tAEs was similar (15% vs. 12%), though pancreatitis was observed exclusively in the covered SEMS group, with a trend toward lower incidence in the uncovered group (10% vs. 0%,
p
= 0.050). Stent removal was performed only in patients with covered SEMS, and all 13 removal attempts were successful.
Conclusion
Laser‐cut SEMS demonstrated similar efficacy to braided stents in the management of MDBO. The covered laser‐cut SEMS was associated with a lower RBO rate than the uncovered SEMS. Additionally, Laser‐cut SEMS can be removed if it is fully covered.