STUDY TYPE: Feasibility study STUDY DESIGN: Prospective, multicenter, single-arm, open-label PRIMARY OBJECTIVE The primary objective is to assess safety of the UNITY Balloon-expandable Biodegradable Biliary Stent System SECONDARY OBJECTIVES Clinical /Technical /Procedural success, Quality of Life improvement, biodegradation rate
Benign fibrotic distal bile duct obstruction
Duct occlusion caused by cholelithiasis
A benign fibrotic distal obstruction of the Common Bile Duct (CBD), demonstrated by presence of a stenosis on magnetic resonance cholangiopancreatography (MRCP) and/or ERCP with proximal ductal dilation and cholestatic liver enzymes levels
Ductal anastomotic strictures
Subject is unwilling to comply with the follow-up schedule
Life expectancy < 12 m,
Inability to pass a guidewire through stricture
Contra-indication for endoscopy or interventional radiology