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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
119
Reintervention can occur in Arm 1 or Arm 2 with either a WallFlex™ Biliary RX Fully Covered or Uncovered Stent System
Indiana University Medical Center
Indianapolis, Indiana, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Virginia Mason Medical Center
Seattle, Washington, United States
The Medical College of Wisconsin
Sustained Biliary Drainage, Defined as Absence of Reinterventions for the Management of Biliary Obstructive Symptoms
Sustained biliary drainage, defined as absence of reinterventions for the management of biliary obstructive symptoms, assessed from self-expanding metal stent (SEMS) placement until curative intent surgery (CIS) when applicable, or to one year after SEMS placement otherwise.
Time frame: 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)
Procedure-related or Stent-related Serious Adverse Events
Serious adverse events related to the stent placement procedure or to the stent
Time frame: From stent placement procedure up to one year after stent placement procedure
Technical Success
Technical success defined as the ability to deploy the stent in a satisfactory position across the stricture; proximal end of the stent is no more than 1-2cm beyond the proximal end of the stricture.
Time frame: During the Stent Placement Procedure
Ability to Complete Neoadjuvant Therapy as Intended Without Stent-related Interruptions of Neoadjuvant Therapy and Without Biliary Reintervention
The ability to complete neoadjuvant therapy as intended without stent-related interruptions of neoadjuvant therapy and without biliary reintervention
Time frame: 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
Number of Participants With Stent Migration
The number of participants with stent migration
Time frame: At the time of curative intent surgery (CIS) (median 110 days to CIS) or transition to palliation for participants not underoing CIS
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Milwaukee, Wisconsin, United States
CUB Hopital Erasme
Brussels, Belgium
Centre Hospitalier de l'Université de Montréal-Saint-Luc Hospital
Montreal, Quebec, Canada
Fondazione Policlinico Universitario Agostino Gemelli
Rome, Italy
Tokyo University Hospital
Tokyo, Japan
Asan Medical Center
Seoul, South Korea
Subjective Impression of the Surgeon That the Presence of a Self-expanding Metal Stent May Have Impacted the Surgical Procedure
The subjective impression of the surgeon that the presence of a self-expanding metal stent (SEMS) may have impacted the surgical procedure.
Time frame: At the time of curative intent surgery (CIS) (median 110 days to CIS)
For Participants Not Undergoing Curative Intent Surgery, Sustained Biliary Drainage to One Year After Stent Placement
For participants not undergoing curative intent surgery, sustained biliary drainage from stent placement to one year after stent placement.
Time frame: From stent placement to one year after stent placement for participants not undergoing curative intent surgery