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