SEMS Placement Before Surgery in Unblocking Bile Duct in Patients With Periampullary Pancreatic Cancer With Severe Obstructive Jaundice

PRIMARY OBJECTIVES:

I. To compare the 30-day overall complication rates between patients with severe obstructive
jaundice undergoing preoperative endoscopic biliary drainage with self expanding metal stents
(SEMS) and patients undergoing direct surgical resection.

Inclusion Criteria:

- Diagnosis of operable peri-ampullary pancreatic cancer as determined by the Department
of Surgery per their standard of care

- Serum bilirubin > 10 mg/dl

- Adequate birth control

Exclusion Criteria:

- Patients with evidence of distant metastasis on computed tomography (CT) or magnetic
resonance imaging (MRI)

- Patients anticipated to require vascular reconstruction

- Patients with cholangitis

- Patients for whom surgery is deemed inappropriate by surgeon

- Patients with bilirubin less than 10 mg/dL or greater than 20 mg/dL

- Patients who previously underwent biliary decompression for cholangitis by ERCP or
percutaneous transhepatic cholangiography (PTC)

- Patients with low performance score (Karnofsky performance status scale < 50)

- Patients with known preexisting liver disease with associated elevated bilirubin

- Patients who are pregnant or actively breast feeding