Evaluating Novel Braided Metal Stent for Bilateral Simultaneous Side-by-Side Stenting in Malignant Hilar Biliary Obstruction: A Multicenter, Single-Arm Prospective Study

评估新型编织金属支架在恶性肝门部胆道梗阻双侧同时并排支架置入术中的应用:一项多中心、单组前瞻性研究

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Abstract

Background: While the side-by-side stenting technique-characterized by the parallel placement of stents offers procedural simplicity, the augmented radial force exerted by the initial stent may complicate subsequent deployment. This multicenter study evaluated the practicality and safety of bilateral side-by-side stenting using novel braided self-expandable metal stents (Benefit(TM); M.I.Tech Co., Ltd., Pyeongtaek, Republic of Korea). Statistical analysis included survival analysis (Kaplan-Meier) and Cox proportional hazards regression to identify predictive factors. Patients and Methods: In this multicenter study, patients with inoperable malignant hilar biliary obstruction (Bismuth type II-IV) underwent simultaneous side-by-side endoscopic placement of two braided self-expandable metal stents. The primary outcome was stent patency. The secondary outcomes included technical and clinical success, and adverse events monitored for up to one year. Results: A total of 27 patients were included in the final analysis. The technical success rate was 92.6% (25/27), and the clinical success rate was 88.0% (22/25). The median stent patency was 93 days, with cumulative patency rates of 87.4% at 3 months and 49.7% at 12 months. Tumor ingrowth was the most common cause of stent occlusion (66.7%). Early adverse events occurred in 2 patients (one cholangitis and one stent migration), supporting the favorable safety profile of this approach. Conclusions: The simultaneous side-by-side placement of novel braided self-expandable metal stents yielded high technical success and favorable clinical outcomes in patients with inoperable malignant hilar biliary obstruction. This approach provided substantial stent patency with a low complication rate, supporting its utility as a safe and effective palliative strategy for the management of malignant hilar biliary obstruction.

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