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Pre-operative Biliary SEMS RCT During Neoadjuvant Therapy

Primary Purpose

Pancreatic Cancer

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
WallFlex™ Biliary RX Fully Covered/Uncovered Stent System
Sponsored by
Boston Scientific Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Cancer focused on measuring Pancreatic, Pancreatic Cancer, Preoperative Biliary Drainage, Neoadjuvant Therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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 Criteria:

  • 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

Sites / Locations

  • Indiana University Medical Center
  • University of Pittsburgh Medical Center
  • Virginia Mason Medical Center
  • The Medical College of Wisconsin
  • CUB Hopital Erasme
  • Centre Hospitalier de l'Université de Montréal-Saint-Luc Hospital
  • Fondazione Policlinico Universitario Agostino Gemelli
  • Tokyo University Hospital
  • Asan Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

WallFlex Biliary RX Fully Covered Stent System

WallFlex Biliary RX Uncovered Stent System

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Procedure-related or Stent-related Serious Adverse Events
Serious adverse events related to the stent placement procedure or to the stent
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.
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
Number of Participants With Stent Migration
The number of participants with stent migration
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.
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.

Full Information

First Posted
May 2, 2014
Last Updated
February 14, 2020
Sponsor
Boston Scientific Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT02238847
Brief Title
Pre-operative Biliary SEMS RCT During Neoadjuvant Therapy
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
March 24, 2015 (Actual)
Primary Completion Date
February 21, 2018 (Actual)
Study Completion Date
April 10, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston Scientific Corporation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer
Keywords
Pancreatic, Pancreatic Cancer, Preoperative Biliary Drainage, Neoadjuvant Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
119 (Actual)

8. Arms, Groups, and Interventions

Arm Title
WallFlex Biliary RX Fully Covered Stent System
Arm Type
Active Comparator
Arm Description
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
Arm Title
WallFlex Biliary RX Uncovered Stent System
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Device
Intervention Name(s)
WallFlex™ Biliary RX Fully Covered/Uncovered Stent System
Intervention Description
Reintervention can occur in Arm 1 or Arm 2 with either a WallFlex™ Biliary RX Fully Covered or Uncovered Stent System
Primary Outcome Measure Information:
Title
Sustained Biliary Drainage, Defined as Absence of Reinterventions for the Management of Biliary Obstructive Symptoms
Description
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)
Secondary Outcome Measure Information:
Title
Procedure-related or Stent-related Serious Adverse Events
Description
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
Title
Technical Success
Description
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
Title
Ability to Complete Neoadjuvant Therapy as Intended Without Stent-related Interruptions of Neoadjuvant Therapy and Without Biliary Reintervention
Description
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
Title
Number of Participants With Stent Migration
Description
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
Title
Subjective Impression of the Surgeon That the Presence of a Self-expanding Metal Stent May Have Impacted the Surgical Procedure
Description
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)
Title
For Participants Not Undergoing Curative Intent Surgery, Sustained Biliary Drainage to One Year After Stent Placement
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yousuke Nakai, MD, PhD
Organizational Affiliation
Tokyo University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dong-Wan Seo, MD
Organizational Affiliation
Asan Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Indiana University Medical Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Virginia Mason Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Facility Name
The Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
CUB Hopital Erasme
City
Brussels
ZIP/Postal Code
1070
Country
Belgium
Facility Name
Centre Hospitalier de l'Université de Montréal-Saint-Luc Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2X 0A9
Country
Canada
Facility Name
Fondazione Policlinico Universitario Agostino Gemelli
City
Rome
ZIP/Postal Code
00168
Country
Italy
Facility Name
Tokyo University Hospital
City
Tokyo
ZIP/Postal Code
113-8655
Country
Japan
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
31276674
Citation
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. Erratum In: Gastrointest Endosc. 2019 Nov;90(5):861. Gastrointest Endosc. 2021 Oct;94(4):880.
Results Reference
derived

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Pre-operative Biliary SEMS RCT During Neoadjuvant Therapy

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