Preoperative Biliary Drainage in Resectable Pancreatic or Periampullary Cancer

Randomized Multi-Center Study Comparing No Drainage to Preoperative Biliary Drainage Using Metal Stents in Patients With Resectable Pancreatic or Periampullary Cancer

The purpose of this study is to demonstrate that preoperative biliary drainage using self-expanding metal stents (SEMS) does not negatively impact overall surgical outcomes in patients undergoing pancreaticoduodenectomy for treatment of pancreatic or periampullary cancer.

Inclusion Criteria:

• Age 18 or older
• Willing and able to comply with the study procedures and provide written informed consent to participate in the study
• Diagnosis of probable pancreatic cancer, distal common bile duct (CBD) cholangiocarcinoma and other periampullary cancers (histology not required)
• Biliary obstructive symptoms or signs
• Bilirubin level at/above 100 umol per liter (5.8 mg/dL)
• Distal biliary obstruction consistent with pancreatic cancer, distal CBD cholangiocarcinoma or other periampullary malignancy
• Location of distal biliary obstruction is such that it would allow the proximal end of a stent to be positioned at least 2cm from the hilum
• Patients deemed as resectable by pancreatic protocol CT or MRI
• Surgical candidate per pancreatobiliary surgeon after multi-disciplinary discussion
• Surgery intent within 4 weeks
• Endoscopic and surgical treatment to be provided by same team

Exclusion Criteria:

• Biliary strictures caused by confirmed benign tumors
• Biliary strictures caused by malignancies other than pancreatic cancer, distal CBD cholangiocarcinoma and other periampullary cancers
• Surgically altered biliary tract anatomy, not including prior cholecystectomy
• Neoadjuvant chemotherapy for current malignancy
• Palliative indication due to reasons other than surgical candidate status
• Previous biliary drainage by ERCP/PTC
• Patients for whom endoscopic techniques are contraindicated
• Participation in another investigational trial within 90 days
• Pregnancy