Pre-operative Biliary SEMS RCT During Neoadjuvant Therapy
NCT ID: NCT02238847
Last Updated: 2020-02-17
Study Results
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View full resultsBasic Information
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COMPLETED
NA
119 participants
INTERVENTIONAL
2015-03-24
2018-04-10
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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WallFlex Biliary RX Fully Covered Stent System
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
WallFlex™ Biliary RX Fully Covered/Uncovered Stent System
Reintervention can occur in Arm 1 or Arm 2 with either a WallFlex™ Biliary RX Fully Covered or Uncovered Stent System
WallFlex Biliary RX Uncovered Stent System
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
WallFlex™ Biliary RX Fully Covered/Uncovered Stent System
Reintervention can occur in Arm 1 or Arm 2 with either a WallFlex™ Biliary RX Fully Covered or Uncovered Stent System
Interventions
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WallFlex™ Biliary RX Fully Covered/Uncovered Stent System
Reintervention can occur in Arm 1 or Arm 2 with either a WallFlex™ Biliary RX Fully Covered or Uncovered Stent System
Eligibility Criteria
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Inclusion Criteria
* Patient indicated for biliary metal stent placement for the treatment of jaundice and/or cholestasis
* Willing and able to comply with the study procedures and provide written informed consent to participate in the study
* Suspicion of pancreatic adenocarcinoma
* Likely indicated for neoadjuvant treatment
* Distal biliary obstruction consistent with pancreatic cancer
* Location of distal biliary obstruction such that it would allow the proximal end of a stent to be positioned at least 2 cm from the hilum
* Endoscopic and surgical treatment to be provided at the same institution
Exclusion Criteria
* Malignancy secondary to Intraductal Papillary Mucinous Neoplasm
* Surgically altered anatomy where ERCP is not possible
* Previous biliary drainage using a SEMS or multiple plastic stents
* Contraindications for endoscopic techniques
* Patients who are currently enrolled in another investigational trial that would directly interfere with the current study
* Pregnancy
18 Years
ALL
No
Sponsors
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Boston Scientific Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Yousuke Nakai, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Tokyo University
Dong-Wan Seo, MD
Role: PRINCIPAL_INVESTIGATOR
Asan Medical Center
Locations
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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
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
Countries
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References
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Seo DW, Sherman S, Dua KS, Slivka A, Roy A, Costamagna G, Deviere J, Peetermans J, Rousseau M, Nakai Y, Isayama H, Kozarek R; Biliary SEMS During Neoadjuvant Therapy Study Group. Covered and uncovered biliary metal stents provide similar relief of biliary obstruction during neoadjuvant therapy in pancreatic cancer: a randomized trial. Gastrointest Endosc. 2019 Oct;90(4):602-612.e4. doi: 10.1016/j.gie.2019.06.032. Epub 2019 Jul 2.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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E7034
Identifier Type: OTHER
Identifier Source: secondary_id
90905950
Identifier Type: -
Identifier Source: org_study_id
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