Clinical trialNACompleted
Pre-operative Biliary SEMS RCT During Neoadjuvant Therapy
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
- Outcome
- Outcome unknown
- Phase
- NA
- Status
- Completed
- Study type
- Interventional
- Start
- 24 March 2015
- Expected end
- 10 April 2018
- Enrollment
- 119 participants
- Sites
- 9
- Primary outcomes
- Sustained Biliary Drainage, Defined as Absence of Reinterventions for the Management of Biliary Obstructive Symptoms
- Sponsor
- Industry
- Results posted
- 2020-02-17
- Last update
- 17 February 2020
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Brief summary public domain (ClinicalTrials.gov)
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.
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
Sustained Biliary Drainage, Defined as Absence of Reinterventions for the Management of Biliary Obstructive Symptoms [From SEMS placement until CIS (for patients undergoing CIS; median 110 days to CIS) or from SEMS placement to one year after SEMS placement (for patients not undergoing CIS)]. Count Of Participants, Participants. WallFlex Biliary RX Fully Covered Stent System (n=54): 39; WallFlex Biliary RX Uncovered Stent System (n=59): 43. Analysis, WallFlex Biliary RX Fully Covered Stent System vs WallFlex Biliary RX Uncovered Stent System: p=<0.01; Exact Non-inferiority; non inferiority.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Procedure-related or Stent-related Serious Adverse Events [From stent placement procedure up to one year after stent placement procedure]. Count Of Participants, Participants. WallFlex Biliary RX Fully Covered Stent System (n=59): 14; WallFlex Biliary RX Uncovered Stent System (n=60): 12. Analysis, WallFlex Biliary RX Fully Covered Stent System vs WallFlex Biliary RX Uncovered Stent System: p=0.66; Fisher Exact; superiority.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Technical Success [During the Stent Placement Procedure]. Count Of Participants, Participants. WallFlex Biliary RX Fully Covered Stent System (n=59): 58; WallFlex Biliary RX Uncovered Stent System (n=60): 60.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Ability to Complete Neoadjuvant Therapy as Intended Without Stent-related Interruptions of Neoadjuvant Therapy and Without Biliary Reintervention [From initial stent placement procedure to curative intent surgery (CIS) (median 110 days to CIS), or from initial stent placement procedure to one year after initial stent placement for participants not undergoing CIS]. Count Of Participants, Participants. WallFlex Biliary RX Fully Covered Stent System (n=55): 53; WallFlex Biliary RX Uncovered Stent System (n=52): 51.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Number of Participants With Stent Migration [At the time of curative intent surgery (CIS) (median 110 days to CIS) or transition to palliation for participants not underoing CIS]. Count Of Participants, Participants. WallFlex Biliary RX Fully Covered Stent System (n=59): 5; WallFlex Biliary RX Uncovered Stent System (n=60): 0.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Subjective Impression of the Surgeon That the Presence of a Self-expanding Metal Stent May Have Impacted the Surgical Procedure [At the time of curative intent surgery (CIS) (median 110 days to CIS)]. Count Of Participants, Participants. WallFlex Biliary RX Fully Covered Stent System (n=24): 3; WallFlex Biliary RX Uncovered Stent System (n=27): 4.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
For Participants Not Undergoing Curative Intent Surgery, Sustained Biliary Drainage to One Year After Stent Placement [From stent placement to one year after stent placement for participants not undergoing curative intent surgery]. Count Of Participants, Participants. WallFlex Biliary RX Fully Covered Stent System (n=30): 19; WallFlex Biliary RX Uncovered Stent System (n=32): 21.