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WallFlex Biliary Fully Covered (FC) Benign Stricture Study

Primary Purpose

Biliary Stricture

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
WallFlex Biliary RX Fully Covered Stent System
Sponsored by
Boston Scientific Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Biliary Stricture focused on measuring benign biliary strictures secondary to chronic pancreatitis/post abdominal surgery/post liver transplant

Eligibility Criteria

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

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 or prior liver transplantation or prior other abdominal surgery (to include cholecystectomy)
  • Indicated for ERCP procedure with stent placement for: Symptomatic bile duct stricture (i.e. obstructive jaundice, persistent cholestasis, acute cholangitis) confirmed by cholangiogram and/or Bile duct stricture confirmed by cholangiogram and/or Exchange of prior plastic stent(s) for management of benign stricture

Exclusion Criteria:

General:

  • Placement of the stent in strictures that cannot be dilated enough to pass the delivery system
  • Placement of the stent in a perforated duct
  • Placement of the stent in very small intrahepatic ducts
  • Patients for whom endoscopic techniques are contraindicated
  • Biliary stricture of malignant etiology
  • Biliary stricture of benign etiology other than chronic pancreatitis or liver transplant anastomosis or other abdominal surgery
  • Stricture within 2 cm of duct bifurcation
  • Symptomatic duodenal stenosis (with gastric stasis)
  • Prior biliary self-expanding metal stent
  • Suspected stricture ischemia based on imaging of hepatic artery occlusion or endoscopic evidence of biliary cast syndrome
  • Known bile duct fistula
  • Known sensitivity to any components of the stent or delivery system
  • Participation in another investigational study within 90 days prior to consent or during the study

Additional Specific to Chronic Pancreatitis Patients:

  • Developing obstructive biliary symptoms associated with an attack of acute pancreatitis

Additional Specific to Post-Abdominal Surgery Patients:

  • History of hepatectomy
  • History of liver transplant

Additional Specific to Liver Transplant Patients:

  • Live donor transplantation

Sites / Locations

  • Westmead Hospital
  • Medical University of Vienna
  • ULB Erasme Hospital
  • St. Michael's Hospital
  • Centre Hospitalier de l'Université de Montréal-Saint-Luc Hospital
  • MUHC - McGill University
  • Clinica Alemana de Santiago
  • Hopital Edouard Herriot
  • Evangelischen Krankenhaus
  • Asian Institute of Gastroenterology
  • Università Cattolica del Sacro Cuore Policlinico A. Gemelli
  • Erasmus Medical Center
  • Hospital Universitari Doctor Josep Trueta

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

WallFlex Biliary RX FC Stent System

Arm Description

The WallFlex Biliary RX Fully Covered Stent System is being evaluated for treatment of benign biliary strictures.

Outcomes

Primary Outcome Measures

Stent Removability
Defined as ability to remove the stent endoscopically without serious stent removal related adverse events as assessed from the time of stent removal to 1month post-stent removal.

Secondary Outcome Measures

Full Information

First Posted
November 13, 2009
Last Updated
February 7, 2020
Sponsor
Boston Scientific Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT01014390
Brief Title
WallFlex Biliary Fully Covered (FC) Benign Stricture Study
Official Title
A Multi-Center, Prospective Study of the WallFlex Biliary RX Fully Covered Stent for the Treatment of Benign Biliary Strictures
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
December 2009 (Actual)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
November 2017 (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 evaluate the safety and performance of the WallFlex® Biliary RX Fully Covered Stent as a treatment of biliary obstruction resulting from benign bile duct strictures.

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/post abdominal surgery/post liver transplant

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
187 (Actual)

8. Arms, Groups, and Interventions

Arm Title
WallFlex Biliary RX FC Stent System
Arm Type
Experimental
Arm Description
The WallFlex Biliary RX Fully Covered Stent System is being evaluated for treatment of benign biliary strictures.
Intervention Type
Device
Intervention Name(s)
WallFlex Biliary RX Fully Covered Stent System
Intervention Description
Temporary placement of a biliary stent as a treatment of biliary obstruction resulting from benign bile duct strictures. The stent is fully covered with a silicone polymer to reduce the potential of tissue ingrowth into the stent. The stent is removed after 5 months (±1 month) after stent placement in Post-Liver Transplant patients and after 11 months (±1 month) in Chronic Pancreatitis and Post-Abdominal Surgery patients.
Primary Outcome Measure Information:
Title
Stent Removability
Description
Defined as ability to remove the stent endoscopically without serious stent removal related adverse events as assessed from the time of stent removal to 1month post-stent removal.
Time Frame
At stent removal

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 or prior liver transplantation or prior other abdominal surgery (to include cholecystectomy) Indicated for ERCP procedure with stent placement for: Symptomatic bile duct stricture (i.e. obstructive jaundice, persistent cholestasis, acute cholangitis) confirmed by cholangiogram and/or Bile duct stricture confirmed by cholangiogram and/or Exchange of prior plastic stent(s) for management of benign stricture Exclusion Criteria: General: Placement of the stent in strictures that cannot be dilated enough to pass the delivery system Placement of the stent in a perforated duct Placement of the stent in very small intrahepatic ducts Patients for whom endoscopic techniques are contraindicated Biliary stricture of malignant etiology Biliary stricture of benign etiology other than chronic pancreatitis or liver transplant anastomosis or other abdominal surgery Stricture within 2 cm of duct bifurcation Symptomatic duodenal stenosis (with gastric stasis) Prior biliary self-expanding metal stent Suspected stricture ischemia based on imaging of hepatic artery occlusion or endoscopic evidence of biliary cast syndrome Known bile duct fistula Known sensitivity to any components of the stent or delivery system Participation in another investigational study within 90 days prior to consent or during the study Additional Specific to Chronic Pancreatitis Patients: Developing obstructive biliary symptoms associated with an attack of acute pancreatitis Additional Specific to Post-Abdominal Surgery Patients: History of hepatectomy History of liver transplant Additional Specific to Liver Transplant Patients: Live donor transplantation
Facility Information:
Facility Name
Westmead Hospital
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Facility Name
Medical University of Vienna
City
Vienna
Country
Austria
Facility Name
ULB Erasme Hospital
City
Brussels
Country
Belgium
Facility Name
St. Michael's Hospital
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
Centre Hospitalier de l'Université de Montréal-Saint-Luc Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2X 3J4
Country
Canada
Facility Name
MUHC - McGill University
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
Clinica Alemana de Santiago
City
Santiago
Country
Chile
Facility Name
Hopital Edouard Herriot
City
Lyon
Country
France
Facility Name
Evangelischen Krankenhaus
City
Dusseldorf
Country
Germany
Facility Name
Asian Institute of Gastroenterology
City
Hyderabad
Country
India
Facility Name
Università Cattolica del Sacro Cuore Policlinico A. Gemelli
City
Rome
ZIP/Postal Code
00168
Country
Italy
Facility Name
Erasmus Medical Center
City
Rotterdam
Country
Netherlands
Facility Name
Hospital Universitari Doctor Josep Trueta
City
Girona
State/Province
Catalunya
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
24801350
Citation
Deviere J, Nageshwar Reddy D, Puspok A, Ponchon T, Bruno MJ, Bourke MJ, Neuhaus H, Roy A, Gonzalez-Huix Llado F, Barkun AN, Kortan PP, Navarrete C, Peetermans J, Blero D, Lakhtakia S, Dolak W, Lepilliez V, Poley JW, Tringali A, Costamagna G; Benign Biliary Stenoses Working Group. Successful management of benign biliary strictures with fully covered self-expanding metal stents. Gastroenterology. 2014 Aug;147(2):385-95; quiz e15. doi: 10.1053/j.gastro.2014.04.043. Epub 2014 May 4.
Results Reference
result
PubMed Identifier
32417298
Citation
Poley JW, Ponchon T, Puespoek A, Bruno M, Roy A, Peetermans J, Rousseau M, Lepilliez V, Dolak W, Tringali A, Blero D, Carr-Locke D, Costamagna G, Deviere J; Benign Biliary Stenoses Working Group. Fully covered self-expanding metal stents for benign biliary stricture after orthotopic liver transplant: 5-year outcomes. Gastrointest Endosc. 2020 Dec;92(6):1216-1224. doi: 10.1016/j.gie.2020.04.078. Epub 2020 May 15.
Results Reference
derived
PubMed Identifier
31830897
Citation
Tringali A, Reddy DN, Ponchon T, Neuhaus H, Llado FG, Navarrete C, Bruno MJ, Kortan PP, Lakhtakia S, Peetermans J, Rousseau M, Carr-Locke D, Deviere J, Costamagna G; Benign Biliary Stenoses Working Group. Treatment of post-cholecystectomy biliary strictures with fully-covered self-expanding metal stents - results after 5 years of follow-up. BMC Gastroenterol. 2019 Dec 12;19(1):214. doi: 10.1186/s12876-019-1129-3.
Results Reference
derived
PubMed Identifier
31494135
Citation
Lakhtakia S, Reddy N, Dolak W, Ponchon T, Bruno MJ, Bourke MJ, Neuhaus H, Roy A, Gonzalez-Huix Llado F, Kortan PP, Peetermans J, Rousseau M, Costamagna G, Deviere J; Benign Biliary Stenoses Working Group. Long-term outcomes after temporary placement of a self-expanding fully covered metal stent for benign biliary strictures secondary to chronic pancreatitis. Gastrointest Endosc. 2020 Feb;91(2):361-369.e3. doi: 10.1016/j.gie.2019.08.037. Epub 2019 Sep 5.
Results Reference
derived
Links:
URL
http://www.ncbi.nlm.nih.gov/pubmed/?term=24801350
Description
Successful management of benign biliary strictures with fully covered self-expanding metal stents.

Learn more about this trial

WallFlex Biliary Fully Covered (FC) Benign Stricture Study

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