Pre-operative Biliary SEMS RCT During Neoadjuvant Therapy

Randomized Controlled Trial Comparing Covered and Uncovered Biliary Self Expanding Metal Stents (SEMS) for Pre-operative Drainage During Neoadjuvant Therapy in Patients With Pancreatic Cancer

The purpose of this study is to demonstrate non-inferiority of Fully Covered biliary SEMS to Uncovered biliary SEMS in biliary drainage for the pre-operative management of biliary obstructive symptoms caused by pancreatic cancer in patients undergoing neoadjuvant therapy.

Inclusion Criteria:

• Age 18 or older
• Patient indicated for biliary metal stent placement for the treatment of jaundice and/or cholestasis
• Willing and able to comply with the study procedures and provide written informed consent to participate in the study
• Suspicion of pancreatic adenocarcinoma
• Likely indicated for neoadjuvant treatment
• Distal biliary obstruction consistent with pancreatic cancer
• Location of distal biliary obstruction such that it would allow the proximal end of a stent to be positioned at least 2 cm from the hilum
• Endoscopic and surgical treatment to be provided at the same institution

Exclusion Criteria:

• Benign biliary strictures
• Malignancy secondary to Intraductal Papillary Mucinous Neoplasm
• Surgically altered anatomy where ERCP is not possible
• Previous biliary drainage using a SEMS or multiple plastic stents
• Contraindications for endoscopic techniques
• Patients who are currently enrolled in another investigational trial that would directly interfere with the current study
• Pregnancy