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
2 other identifiers
interventional
119
6 countries
9
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 caused by pancreatic cancer in patients undergoing neoadjuvant therapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable pancreatic-cancer
Started Mar 2015
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 2, 2014
CompletedFirst Posted
Study publicly available on registry
September 12, 2014
CompletedStudy Start
First participant enrolled
March 24, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 21, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
April 10, 2018
CompletedResults Posted
Study results publicly available
February 17, 2020
CompletedFebruary 17, 2020
February 1, 2020
2.9 years
May 2, 2014
July 25, 2019
February 14, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
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)
Secondary Outcomes (6)
Procedure-related or Stent-related Serious Adverse Events
From stent placement procedure up to one year after stent placement procedure
Technical Success
During the Stent Placement Procedure
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
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
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)
- +1 more secondary outcomes
Study Arms (2)
WallFlex Biliary RX Fully Covered Stent System
ACTIVE COMPARATORPatients 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 Uncovered Stent System
ACTIVE COMPARATORPatients 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
Interventions
Reintervention can occur in Arm 1 or Arm 2 with either a WallFlex™ Biliary RX Fully Covered or Uncovered Stent System
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
Indiana University Medical Center
Indianapolis, Indiana, 46202, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213, United States
Virginia Mason Medical Center
Seattle, Washington, 98101, United States
The Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
CUB Hopital Erasme
Brussels, 1070, Belgium
Centre Hospitalier de l'Université de Montréal-Saint-Luc Hospital
Montreal, Quebec, H2X 0A9, Canada
Fondazione Policlinico Universitario Agostino Gemelli
Rome, 00168, Italy
Tokyo University Hospital
Tokyo, 113-8655, Japan
Asan Medical Center
Seoul, 138-736, South Korea
Related Publications (1)
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.
PMID: 31276674DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Lina Ginnetti, Clinical Endoscopy Director
- Organization
- Boston Scientific Corporation
Study Officials
- PRINCIPAL INVESTIGATOR
Yousuke Nakai, MD, PhD
Tokyo University
- PRINCIPAL INVESTIGATOR
Dong-Wan Seo, MD
Asan Medical Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 2, 2014
First Posted
September 12, 2014
Study Start
March 24, 2015
Primary Completion
February 21, 2018
Study Completion
April 10, 2018
Last Updated
February 17, 2020
Results First Posted
February 17, 2020
Record last verified: 2020-02