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
Single group
Biliary Duct Stenting
DeviceUNITY-B Balloon-expandable Biodegradable Biliary Stent deployment in obstructed biliary ducts.
Safety Complication Rate for the first 30days
Total number of all complications is calculated as aggregate for the duration 30 days (day zero till day30 after index procedure). Two-sided 95% confidence intervals is constructed using exact (Clopper-Pearson) method.
Efficacy Rates of Clinical Success
Endpoints are analysed descriptively. Qualitative parameters are described by their distribution (frequencies and %); quantitative parameters are described by their mean, (SD±), min.-max., related to subjects with assessable data. Clinical Success; Normal serum bilirubin level (SBL) within 14 days after intervention. Relief of jaundice and pruritus. SBL is assessed directly before procedure day and at day14. Difference between both dates is calculated. Presence and absence of pruritus and jaundice shall behave accordingly to SBL. Postulated achieving a 20% reduction of SBL within the first 14days. Presence and absence of pruritus and jaundice is assessed and recorded at both SBL control dates.
Efficacy Rates of Technical Success
Technical Success; Total number of completed stent deployment.
Click on the lead sponsor to view all of their trials.
