A Multicenter Prospective Feasibility Study of a Novel Rapid-Exchange Biliary Stent Delivery System Enabling Sequential Stent Placement with Index Guidewire Retention

Background and Aims Biliary stenting is essential for the management of biliary obstruction. All plastic biliary stent delivery systems in the United States require withdrawal of the guidewire upon stent deployment, mandating repeat cannulation when additional stents are required. A novel multiple biliary stent delivery system with a self-detaching tip preserves the index guidewire in situ after stent release, enabling rapid sequential placement of additional plastic stents. We report the first-in-human multicenter clinical experience with this device. Methods This was a prospective feasibility pilot study at 7 international tertiary referral centers. Endoscopists were trained using a 2-minute video and bedside proctoring. Adult patients undergoing endoscopic retrograde cholangiopancreatography (ERCP) with the novel system between 2023 and 2024 were enrolled. Primary endpoints were technical success of stent deployment and index guidewire retention. Secondary endpoints included stents placed per session, ability to advance the system to the intended location, immediate adverse events (AE), and endoscopist-reported usability. Results Twenty-five patients underwent ERCP with the novel system. Between 1 and 4 plastic stents were placed in parallel per session. Technical success was achieved in 24 of 25 cases (96.0%); one stent could not be delivered owing to severe ampullary angulation. The index guidewire was retained in situ in 100% of successfully delivered stents. Conclusion In this first-in-human multicenter experience, a novel rapid-exchange biliary stent delivery system with a self-detaching tip enabled sequential parallel plastic stent placement without removal of the index guidewire, with high technical success and no immediate procedure-related adverse events. Further prospective comparative study is warranted.