Prospective Evaluation of Stent Patency in Patients With Benign Biliary Obstruction of the Wing Biliary Stent (Viaduct™)

Fifty patients that meet all the inclusion criteria and have none of the exclusion criteria will be invited to participate in the study. Initial visit: Written informed consent will be obtained Complete history and physical will be performed and the patients baseline liver function tests and imaging results will be assessed and noted in the case report form. Patients gender, date of birth, concomitant medications will be noted. Procedure: Patients will then be scheduled for the ERCP procedure with wing biliary stent placement. They will undergo the ERCP as standard of care and the wing biliary stent will be placed for decompression of the obstructed biliary system in situations where stenting is standard of care. One or more biliary stents may be placed during the procedure depending on the indication such as a biliary stricture necessitating multiple stent placements for dilation as the standard of care. Bloodwork: Patients will undergo bloodwork (total and direct bilirubin, alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase) one week after the procedure. The degree of drop in bilirubin will also be noted. The patients will be then have these labs drawn again at 4, 8 and 12 weeks after the procedure. Telephone calls: The patients will be called on the telephone at weeks 2, 4, 6, 8, 10 after the procedure to monitor their clinical status. Patients and family members will be given a contact number to call us immediately if they develop any signs of biliary obstruction such as fever, abdominal pain, jaundice, dark urine or light stools. They will also be instructed to come to the emergency room should they develop fevers. Stent removal: At the end of 90 days from the stent placement patients will return for a repeat ERCP for stent removal as the standard of care and further endo-therapy as indicated. Stent patency will be calculated from the time of stent insertion up to the end of 90 days. The stent patency rate at 90 days will be the proportion of stents placed that do not occlude over this time period. Stent occlusion will be defined as biochemical or clinical evidence of obstructive jaundice. All the continuous and outcome variables (stent obstruction) will be statistically analyzed and stent malfunction rates will be analyzed for the wing stent across the various indications.