WallFlex Biliary Fully Covered (FC) Benign Stricture Study

A Multi-Center, Prospective Study of the WallFlex Biliary RX Fully Covered Stent for the Treatment of Benign Biliary Strictures

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.

Study Overview

• Status: Completed
• Conditions: Biliary Stricture
• Intervention / Treatment: Device: WallFlex Biliary RX Fully Covered Stent System

• Study Type: Interventional
• Enrollment (Actual): 187
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Westmead, New South Wales, Australia, 2145
      • Westmead Hospital
• Austria
  • Vienna, Austria
    • Medical University of Vienna
• Belgium
  • Brussels, Belgium
    • ULB Erasme Hospital
• Canada
  • Ontario
    • Toronto, Ontario, Canada
      • St. Michael's Hospital
  • Quebec
    • Montreal, Quebec, Canada, H2X 3J4
      • Centre Hospitalier de l'Université de Montréal-Saint-Luc Hospital
    • Montreal, Quebec, Canada
      • MUHC - McGill University
• Chile
  • Santiago, Chile
    • Clinica Alemana de Santiago
• France
  • Lyon, France
    • Hôpital Edouard Herriot
• Germany
  • Dusseldorf, Germany
    • Evangelischen Krankenhaus
• India
  • Hyderabad, India
    • Asian Institute Of Gastroenterology
• Italy
  • Rome, Italy, 00168
    • Università Cattolica del Sacro Cuore Policlinico A. Gemelli
• Netherlands
  • Rotterdam, Netherlands
    • Erasmus Medical Center
• Spain
  • Catalunya
    • Girona, Catalunya, Spain
      • Hospital Universitari Doctor Josep Trueta

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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

Device: WallFlex Biliary RX Fully Covered Stent System; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At stent removal

Collaborators and Investigators

• Sponsor: Boston Scientific Corporation

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Helpful Links

• Successful management of benign biliary strictures with fully covered self-expanding metal stents.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2009
• Primary Completion (Actual): November 1, 2012
• Study Completion (Actual): November 1, 2017

Study Registration Dates

• First Submitted: November 13, 2009
• First Submitted That Met QC Criteria: November 16, 2009
• First Posted (Estimate): November 17, 2009

Study Record Updates

• Last Update Posted (Actual): February 19, 2020
• Last Update Submitted That Met QC Criteria: February 7, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: benign biliary strictures secondary to chronic pancreatitis/post abdominal surgery/post liver transplant
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathological Conditions, Anatomical; Biliary Tract Diseases; Bile Duct Diseases; Constriction, Pathologic; Cholestasis
• Other Study ID Numbers: CDM 00027550