Clinical trialNACompleted
Preoperative Biliary Drainage in Resectable Pancreatic or Periampullary Cancer
Randomized Multi-Center Study Comparing No Drainage to Preoperative Biliary Drainage Using Metal Stents in Patients With Resectable Pancreatic or Periampullary Cancer
- Outcome
- Outcome unknown
- Phase
- NA
- Status
- Completed
- Study type
- Interventional
- Start
- 20 February 2013
- Expected end
- 13 December 2021
- Enrollment
- 284 participants
- Sites
- 11
- Primary outcomes
- 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
- Sponsor
- Industry
- Results posted
- 2023-04-10
- Last update
- 10 April 2023
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Brief summary public domain (ClinicalTrials.gov)
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.
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
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 [120 to 150 days]. Count Of Participants, Participants. WallFlex™ Biliary RX Fully Covered/Uncovered Stent System (n=138): 40; None (No Pre-Operative Biliary Drainage) (n=136): 36.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Stent Placement Success [Procedure]. Count Of Participants, Participants. WallFlex™ Biliary RX Fully Covered/Uncovered Stent System (n=141): 140.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Number of Patients With Biliary Re-interventions [120 to 150 days]. Count Of Participants, Participants. WallFlex™ Biliary RX Fully Covered/Uncovered Stent System (n=144): 8; None (No Pre-Operative Biliary Drainage) (n=140): 12.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Success Rate of Curative Intent Surgery [4 weeks]. Count Of Participants, Participants. WallFlex™ Biliary RX Fully Covered/Uncovered Stent System (n=118): 103; None (No Pre-Operative Biliary Drainage) (n=129): 115.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
All-cause Mortality [150 days]. Count Of Participants, Participants. WallFlex™ Biliary RX Fully Covered/Uncovered Stent System (n=144): 11; None (No Pre-Operative Biliary Drainage) (n=140): 11.