UNITY-B A Prospective, Multicentric, Single-arm Study to Evaluate the Safety and Efficacy of the UNITY-B Biodegradable Balloon-Expandable Biliary Stent System in Subjects With Biliary Strictures

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

Inclusion Criteria: * 1\) A subject with a biliary stricture may be entered into the study with: at least one of the following: * 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 * Malignant Biliary stricture at least 1 cm distal to the hilum as well as periampullary hilar strictures not involving the papilla. * Neoplasm diagnosed on clinical and imaging findings * Post-ERCP pancreatitis * Obstructive jaundice with evidence of pruritus, tea color urine and pale stool * Abnormal Bilirubin rate or * A planned exchange of plastic stents previously placed for management of symptomatic biliary stricture or * A previous Percutaneous Transhepatic Biliary Drainage (PTBD) for management of symptomatic biliary stricture 2) Age ≥ 18 years old Exclusion Criteria: Patients, male or female, presenting with the following criteria may be included: 1. Subject is unwilling to comply with the follow-up schedule 2. Life expectancy \< 12 m, 3. Inability to pass a guidewire through stricture 4. Contra-indication for endoscopy or interventional radiology 5. History of allergic reactions to one of the compounds of investigational product. 6. Subject is unable or refuses to give informed consent 7. Subject is pregnant or breastfeeding 8. Patient under tutorship 9. Currently participating in another trial before reaching first endpoint. 10. Pseudo Klatskin tumors (metastases in the liver hilum) and gallbladder carcinoma 11. Patient need additional biliary stenting with another device than the study device. \-