Evaluating a New Lumen-Apposing Metal Stent for EUS-Guided Hepaticogastrostomy in Malignant Biliary Obstruction After Failed ERCP

What this Trial Is About

This research aims to evaluate a new device for EUS-guided hepaticogastrostomy in patients with malignant biliary obstruction who have failed or have difficult ERCP procedures. The study focuses on assessing the feasibility, safety, and outcomes of a novel lumen apposing metal stent designed to prevent migration and improve procedural success. Patients will receive EUS-guided hepaticogastrostomy using the MG-biliary stent made of nitinol with silicone covering. The stent is partially covered, with one end uncovered for placement in intrahepatic ducts and a self-folding flange at the other end to prevent migration outside the stomach. Stent sizes vary in diameter 8 or 10 mm and length 6 to 12 cm. Participants will be monitored for safety and success, including adverse events within 30 days, technical success at 1 day, clinical success at 7 days, and stent patency over 1 year. Follow-up includes clinical assessments and evaluations of the stents function. The total duration and detailed schedules are determined by clinical needs and outcomes.

EUS-guided Hepatico-gastrostomy Using a Novel Lumen Apposing Metal Stent