Braided-type stent versus laser-cut-type stent for patients with unresectable distal malignant biliary obstruction: a randomized controlled trial

Abstract

Background and AimsFully covered self-expandable metallic stents (SEMS) are laser-cut (L) or braided (B); however, which is more effective for distal malignant biliary obstruction (DMBO) has been unclear. We compared the clinical outcomes of using L- type and B-type stents because we believe that recurrent biliary obstruction (RBO) is less likely to occur with L-type stents. MethodsPatients diagnosed with unresectable DMBO were randomly assigned to groups L and B in a stratified block fashion, and outcomes were compared. The primary outcome was the rate of RBO within 1 year; secondary outcomes were adverse events, clinical success rate, time to RBO (TRBO), and overall survival. ResultsOf the 60 enrolled participants, 56 (group L: 27, group B: 29) were included. The rates of RBO within 1 year were 44.4% and 17.2% in groups L and B, respectively (odds ratio 2.57 [95% confidence interval {CI}: 1.045–6.353]). Early adverse events, which improved with conservative treatment, included pancreatitis (n=4) in group L and pancreatitis (n=3) and cholecystitis (n=1) in group B (p=0.913). The median TRBO (220 days [95% CI: 56-272] versus 418 days [95% CI: 232-454]) was significantly longer in group B than in group L (log-rank test, p=0.0118). The median overall survival (L: 158 days, B: 204 days) after stenting was not significantly different between the groups (p=0.8544). ConclusionsIn the setting of DMBO, braided (B)-type stents are associated with less recurrent obstruction than laser-cut-type (L) stents, although there was no difference in safety.