Preoperative Biliary Drainage in Resectable Pancreatic or Periampullary Cancer

Official Title

Randomized Multi-Centre 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.

Trial Description

Primary Outcome:

  • Number of serious pre-operative, operative and post-operative adverse events to 120 days post randomization or to 30 days post surgery, whichever comes last
Secondary Outcome:
  • Number of adverse events
  • Time to surgery
  • Curative Intent Surgery details pertaining to intraoperative assessment of resectability, surgical resection and reconstruction techniques.
  • Amount of intraoperative blood loss and number of blood transfusions, duration of surgery
  • Biliary obstructive symptoms assessment
  • Improvement of liver function test (LFT) levels as relative to baseline
  • Stent placement success
  • Stent removal success
  • Number, type, reason, and timing of biliary re-interventions
  • Number of hospital and ICU admissions
  • Duration of hospital and ICU admissions

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Canadian Cancer Society

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