Status:
COMPLETED
Pre-operative Biliary SEMS RCT During Neoadjuvant Therapy
Lead Sponsor:
Boston Scientific Corporation
Conditions:
Pancreatic Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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...
Eligibility Criteria
Inclusion
- Age 18 or older
- 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
- Benign biliary strictures
- 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
Key Trial Info
Start Date :
March 24 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 10 2018
Estimated Enrollment :
119 Patients enrolled
Trial Details
Trial ID
NCT02238847
Start Date
March 24 2015
End Date
April 10 2018
Last Update
February 17 2020
Active Locations (9)
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1
Indiana University Medical Center
Indianapolis, Indiana, United States, 46202
2
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
3
Virginia Mason Medical Center
Seattle, Washington, United States, 98101
4
The Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226