Your session is about to expire
← Back to Search
Stent
Pre-operative Biliary SEMS RCT During Neoadjuvant Therapy
N/A
Waitlist Available
Led By Yousuke Nakai, MD, PhD
Research Sponsored by Boston Scientific Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at the time of curative intent surgery (cis) (median 110 days to cis) or transition to palliation for participants not underoing cis
Awards & highlights
No Placebo-Only Group
Summary
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.
Eligible Conditions
- Pancreatic Cancer
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from stent placement to one year after stent placement for participants not undergoing curative intent surgery
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from stent placement to one year after stent placement for participants not undergoing curative intent surgery
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Sustained Biliary Drainage, Defined as Absence of Reinterventions for the Management of Biliary Obstructive Symptoms
Secondary study objectives
Ability to Complete Neoadjuvant Therapy as Intended Without Stent-related Interruptions of Neoadjuvant Therapy and Without Biliary Reintervention
For Participants Not Undergoing Curative Intent Surgery, Sustained Biliary Drainage to One Year After Stent Placement
Number of Participants With Stent Migration
+3 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Active Control
Group I: WallFlex Biliary RX Fully Covered Stent SystemActive Control1 Intervention
Patients in this group will receive a fully covered study SEMS (self-expanding metal stent)
Reintervention can occur with either a WallFlex™ Biliary RX Fully Covered or Uncovered Stent System
Group II: WallFlex Biliary RX Uncovered Stent SystemActive Control1 Intervention
Patients in this group will receive an uncovered study SEMS (self-expanding metal stent).
Reintervention can occur with either a WallFlex™ Biliary RX Fully Covered or Uncovered Stent System
Find a Location
Who is running the clinical trial?
Boston Scientific CorporationLead Sponsor
746 Previous Clinical Trials
857,870 Total Patients Enrolled
Yousuke Nakai, MD, PhDPrincipal InvestigatorTokyo University
Dong-Wan Seo, MDPrincipal InvestigatorAsan Medical Center