Pre-operative Biliary SEMS RCT During Neoadjuvant Therapy

Official Title

Randomized Controlled Trial Comparing Covered and Uncovered Biliary Self Expanding Metal Stents (SEMS) for Pre-operative Drainage During Neoadjuvant Therapy in Patients With Pancreatic Cancer


The purpose of this study is to demonstrate non-inferiority of Fully Covered biliary SEMS to Uncovered biliary SEMS in biliary drainage for the pre-operative management of biliary obstructive symptoms caused by pancreatic cancer in patients undergoing neoadjuvant therapy.

Trial Description

Primary Outcome:

  • Successful pre-operative biliary drainage defined as absence of reinterventions for the management of biliary obstructive symptoms.
Secondary Outcome:
  • Occurrence and severity of adverse events
  • Occurrence and severity of surgical complications
  • Occurrence and severity of peri-surgical complications
  • Stent Placement Success
  • Improvement of biliary obstructive symptoms as relative to baseline
  • Improvement of Laboratory Liver Function Tests (LFTs) as relative to baseline
  • Number of biliary re-interventions
  • Ability to complete neoadjuvant therapy as intended without stent related interruptions of neoadjuvant therapy
  • Stent migration rate
  • Assessment by surgeon of interference, if any, of SEMS on time to surgery and/or success of pancreaticoduodenectomy
  • For patients transitioning to palliative management: Successful biliary drainage defined as absence of reinterventions for the management of biliary obstructive symptoms from stent placement to 1 year after stent placement
  • Type of biliary re-interventions
  • Reason of biliary re-interventions
  • Timing of biliary re-interventions

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Canadian Cancer Society

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