WallFlex Biliary Fully Covered (FC) Chronic Pancreatitis Study
Primary Purpose
Biliary Stricture
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
WallFlex™ Biliary RX Fully Covered Stent System RMV
Commercially available Plastic Stent Per Investigator preference
Sponsored by
About this trial
This is an interventional treatment trial for Biliary Stricture focused on measuring benign biliary strictures secondary to chronic pancreatitis
Eligibility Criteria
Inclusion Criteria:
- Age 18 or older
- Willing and able to comply with the study procedures and provide written informed consent to participate in the study
- Chronic pancreatitis
- Symptomatic bile duct stricture (defined by cholangitis or persistent jaundice for at least one month or cholestasis associated with at least 3 times normal alkaline phosphatase levels) documented at time of enrollment for naïve stricture or at the time of prior plastic stent placement in strictures that had one prior plastic stent inserted.12
- Common bile duct stricture based on imaging assessment of dilatation of the common and/or intrahepatic bile ducts
Exclusion Criteria:
- Biliary stricture of benign etiology other than chronic pancreatitis
- Prior biliary metal stent or any plastic stenting other than one plastic stent of 10 Fr or less for 6 months or fewer
- Developing obstructive biliary symptoms associated with an attack of acute pancreatitis
- Biliary stricture of malignant etiology
- Stricture within 2 cm of common bile duct bifurcation
- Known bile duct fistula or leak
- Subjects for whom endoscopic techniques are contraindicated
- Known sensitivity to any components of the stent or delivery system
- Symptomatic duodenal stenosis (with gastric stasis)
- Participation in another investigational study within 90 days prior to consent
- Investigator Discretion
Sites / Locations
- Royal Prince Alfred Medical Center
- Westmead Hospital
- Allgemeines Krankenhaus AKH
- Erasme Hospital
- UZ Gasthuisberg
- CHUM - Hopital Saint-Luc
- Hopital Edouard Herriot
- Evangelisches Krankenhaus Dusseldorf
- Prince of Wales Hospital
- Asian Institute of Gastroenterology
- Azienda Ospedaliera Universitaria Integrata di Verona
- Policlinico Universitario Agostino Gemelli
- Erasmus Medical Center
- Karolinska Universitets Sjukhuset
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Metal stents
Plastic Stents
Arm Description
The WallFlex Biliary Fully Covered Stent System is being evaluated for treatment of benign biliary strictures secondary to chronic pancreatitis.
Plastic stents per Investigator preference are being evaluated for treatment of benign biliary strictures secondary to chronic pancreatitis.
Outcomes
Primary Outcome Measures
Number of Participants With Stricture Resolution
Stricture resolution defined as absence of re-stenting after the 12-month stenting period, and 24 months serum alkaline phosphatase level not exceeding twice the level at the end of stenting period.
Secondary Outcome Measures
Serious Adverse Events Related to the Device or Procedure
Device or procedure related serious adverse events from the initial stent placement procedure to the 24 month follow-up.
Number of ERCP Procedures Through 24 Months After Initial Stent Placement.
The number of endoscopic retrograde cholangiopancreatography (ERCP) procedures through 24 months, after initial stent placement.
Ability to Deploy Stent(s) in Satisfactory Position (Technical Success)
Technical success defined as the ability to deploy the stent(s) in satisfactory position during initial stent placement procedure.
Length of Stent Placement and Removal Procedures
Length of stent placement procedures and stent removal procedures.
Number of Stents Placed
Number of stents placed throughout study to 24 month follow-up
Full Information
NCT ID
NCT01543256
First Posted
February 14, 2012
Last Updated
April 11, 2022
Sponsor
Boston Scientific Corporation
1. Study Identification
Unique Protocol Identification Number
NCT01543256
Brief Title
WallFlex Biliary Fully Covered (FC) Chronic Pancreatitis Study
Official Title
A Multi-Center, Prospective, Randomized Study Comparing Removable, Self-Expanding Metal Stents to Plastic Stents for the Treatment of Benign Biliary Strictures Secondary to Chronic Pancreatitis
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
September 18, 2012 (Actual)
Primary Completion Date
September 21, 2020 (Actual)
Study Completion Date
September 21, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston Scientific Corporation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this of this study is to compare the use of Self Expanding Metal Stents (SEMS) to plastic stents for the treatment of benign biliary strictures secondary to chronic pancreatitis as it pertains to stricture resolution rates, complication rates and number of endoscopic retrograde cholangiopancreatography (ERCP) procedures during 24 months.
Statistical testing will be performed to determine if the rate of stricture resolution for the metal stent is non-inferior to the plastic stent group.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Biliary Stricture
Keywords
benign biliary strictures secondary to chronic pancreatitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
172 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Metal stents
Arm Type
Active Comparator
Arm Description
The WallFlex Biliary Fully Covered Stent System is being evaluated for treatment of benign biliary strictures secondary to chronic pancreatitis.
Arm Title
Plastic Stents
Arm Type
Active Comparator
Arm Description
Plastic stents per Investigator preference are being evaluated for treatment of benign biliary strictures secondary to chronic pancreatitis.
Intervention Type
Device
Intervention Name(s)
WallFlex™ Biliary RX Fully Covered Stent System RMV
Intervention Description
Temporary placement of the WallFlex Biliary RX Fully Covered Stent for treatment of benign biliary strictures secondary to chronic pancreatitis. The stent will be removed after 12 months indwell. ("RMV" in intervention name indicates "removable")
Intervention Type
Device
Intervention Name(s)
Commercially available Plastic Stent Per Investigator preference
Intervention Description
Temporary placement/exchange of multiple biliary plastic stents for treatment of benign biliary strictures secondary to chronic pancreatitis. Stents will be removed after cumulative indwell of 12 months.
Primary Outcome Measure Information:
Title
Number of Participants With Stricture Resolution
Description
Stricture resolution defined as absence of re-stenting after the 12-month stenting period, and 24 months serum alkaline phosphatase level not exceeding twice the level at the end of stenting period.
Time Frame
After 12-month stenting period through 24 month follow-up (approximately 12 months)
Secondary Outcome Measure Information:
Title
Serious Adverse Events Related to the Device or Procedure
Description
Device or procedure related serious adverse events from the initial stent placement procedure to the 24 month follow-up.
Time Frame
Initial stent placement procedure to 24 month follow-up
Title
Number of ERCP Procedures Through 24 Months After Initial Stent Placement.
Description
The number of endoscopic retrograde cholangiopancreatography (ERCP) procedures through 24 months, after initial stent placement.
Time Frame
Initial stent placement procedure to 24 month follow-up
Title
Ability to Deploy Stent(s) in Satisfactory Position (Technical Success)
Description
Technical success defined as the ability to deploy the stent(s) in satisfactory position during initial stent placement procedure.
Time Frame
Initial stent placement procedure
Title
Length of Stent Placement and Removal Procedures
Description
Length of stent placement procedures and stent removal procedures.
Time Frame
Initial stent placement procedure to 24 month follow-up
Title
Number of Stents Placed
Description
Number of stents placed throughout study to 24 month follow-up
Time Frame
Initial stent placement procedure to 24 month follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age 18 or older
Willing and able to comply with the study procedures and provide written informed consent to participate in the study
Chronic pancreatitis
Symptomatic bile duct stricture (defined by cholangitis or persistent jaundice for at least one month or cholestasis associated with at least 3 times normal alkaline phosphatase levels) documented at time of enrollment for naïve stricture or at the time of prior plastic stent placement in strictures that had one prior plastic stent inserted.12
Common bile duct stricture based on imaging assessment of dilatation of the common and/or intrahepatic bile ducts
Exclusion Criteria:
Biliary stricture of benign etiology other than chronic pancreatitis
Prior biliary metal stent or any plastic stenting other than one plastic stent of 10 Fr or less for 6 months or fewer
Developing obstructive biliary symptoms associated with an attack of acute pancreatitis
Biliary stricture of malignant etiology
Stricture within 2 cm of common bile duct bifurcation
Known bile duct fistula or leak
Subjects for whom endoscopic techniques are contraindicated
Known sensitivity to any components of the stent or delivery system
Symptomatic duodenal stenosis (with gastric stasis)
Participation in another investigational study within 90 days prior to consent
Investigator Discretion
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
D.Nageshwar Reddy, MD
Organizational Affiliation
Asian Institute of Gastroenterology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal Prince Alfred Medical Center
City
Newtown
State/Province
New South Wales
ZIP/Postal Code
2042
Country
Australia
Facility Name
Westmead Hospital
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Facility Name
Allgemeines Krankenhaus AKH
City
Vienna
ZIP/Postal Code
A-1090
Country
Austria
Facility Name
Erasme Hospital
City
Brussels
ZIP/Postal Code
1070
Country
Belgium
Facility Name
UZ Gasthuisberg
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
CHUM - Hopital Saint-Luc
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2X 3J4
Country
Canada
Facility Name
Hopital Edouard Herriot
City
Lyon
ZIP/Postal Code
69437
Country
France
Facility Name
Evangelisches Krankenhaus Dusseldorf
City
Dusseldorf
ZIP/Postal Code
D-40217
Country
Germany
Facility Name
Prince of Wales Hospital
City
Shatin
State/Province
New Territories
Country
Hong Kong
Facility Name
Asian Institute of Gastroenterology
City
Hyderabad
ZIP/Postal Code
500 082
Country
India
Facility Name
Azienda Ospedaliera Universitaria Integrata di Verona
City
Verona
State/Province
VR
ZIP/Postal Code
37134
Country
Italy
Facility Name
Policlinico Universitario Agostino Gemelli
City
Rome
ZIP/Postal Code
00168
Country
Italy
Facility Name
Erasmus Medical Center
City
Rotterdam
State/Province
CE
ZIP/Postal Code
3015
Country
Netherlands
Facility Name
Karolinska Universitets Sjukhuset
City
Stockholm
ZIP/Postal Code
S-14186
Country
Sweden
12. IPD Sharing Statement
Citations:
PubMed Identifier
33741314
Citation
Ramchandani M, Lakhtakia S, Costamagna G, Tringali A, Puspoek A, Tribl B, Dolak W, Deviere J, Arvanitakis M, van der Merwe S, Laleman W, Ponchon T, Lepilliez V, Gabbrielli A, Bernardoni L, Bruno MJ, Poley JW, Arnelo U, Lau J, Roy A, Bourke M, Kaffes A, Neuhaus H, Peetermans J, Rousseau M, Reddy DN. Fully Covered Self-Expanding Metal Stent vs Multiple Plastic Stents to Treat Benign Biliary Strictures Secondary to Chronic Pancreatitis: A Multicenter Randomized Trial. Gastroenterology. 2021 Jul;161(1):185-195. doi: 10.1053/j.gastro.2021.03.015. Epub 2021 Mar 17.
Results Reference
derived
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WallFlex Biliary Fully Covered (FC) Chronic Pancreatitis Study
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