Abstract
BACKGROUND AND AIMS: Endoscopic palliation of obstructive jaundice from distal malignant biliary obstruction (dMBO) improves the quality of life of patients. This study aims to compare the clinical outcomes at 6 months after implantation of traditional fully covered self-expandable metal stents (FCSEMSs) versus those with antimigration fins (FCSEMS-AF) in patients with dMBO. METHODS: Individuals undergoing FCSEMS or FCSEMS-AF placement for dMBO from May 2017 to September 2023 were identified. Outcomes included intervention-free stent patency, reintervention rates, time to endoscopic reintervention, clinical success, and adverse events (AEs). Analysis included Kaplan-Meier curves and Cox proportional hazards models. RESULTS: The cohort included 215 patients (142 with FCSEMSs and 73 with FCSEMSs-AF). Clinical success was similar in both groups (93.7% in FCSEMSs vs 95.9% in FCSEMSs-AF; P = .500). At 6 months, 84.8% of FCSEMSs had intervention-free patency compared to 77.1% of FCSEMSs-AF (P = .461), with similar rates of AEs (16.2% in FCSEMS and 21.7% in FCSEMS-AF groups; P = .335) and reintervention (16.2% of FCSEMSs and 22.1% of FCSEMSs-AF; P = .324). At 6 months, FCSEMSs-AF had higher rates of stent occlusion (13.2% of FCSEMSs vs 28.3% of FCSEMSs-AF; P = .011) and lower rates of migration (7.6% of FCSEMSs vs 0% of FCSEMSs-AF; P = .011). After adjusting for stent length, FCSEMSs had a higher risk of migration (hazard ratio 12.23 [95% CI, 1.9-78.66]; P = .008) with similar occlusion risk (hazard ratio 0.68 [95% CI, 0.31-1.51]; P = .342). CONCLUSIONS: FCSEMSs and FCSEMSs-AF have similar performance characteristics at 6 months; however FCSEMSs were more likely to migrate and had similar occlusion risk after stent length adjustment. These findings can provide insight into the current limitations and help guide future stent design.