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

Summary:

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

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society