This trial studies the side effects of self expanding metal stent (SEMS) placement before surgery in unblocking the bile duct in patients with periampullary pancreatic cancer with severe obstructive jaundice. SEMS placement unblocks the bile duct and may help in improving bile drainage prior to surgery 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
4
Undergo ERCP with SEMS placement
Undergo standard of care surgical resection
Sidney Kimmel Cancer Center at Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Complication Rates of Grade III or Higher
The risk difference will be calculated (stent minus control) with a one-sided 95% confidence interval.
Time frame: At 30 days post-surgery
Intraoperative Estimated Blood Loss
Group comparisons will be performed using two sample t-tests or Wilcoxon rank sum tests.
Time frame: At time of surgery
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