WallFlex Biliary Fully Covered (FC) Benign Stricture Study

NCT01014390 | Completed Phase 3 Results

• 1 other identifier: CDM 00027550
• Study Type: interventional
• Target: 187
• Locations: 10 countries
• Sites: 12

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.

Conditions

Biliary Stricture

Keywords

benign biliary strictures secondary to chronic pancreatitis/post abdominal surgery/post liver transplant

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

WallFlex Biliary RX FC Stent System

EXPERIMENTAL

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

Interventions

WallFlex Biliary RX Fully Covered Stent System DEVICE

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.

WallFlex Biliary RX FC Stent System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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:

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (13)

Westmead Hospital

Westmead, New South Wales, 2145, Australia

Location

Medical University of Vienna

Vienna, Austria

Location

ULB Erasme Hospital

Brussels, Belgium

Location

St. Michael's Hospital

Toronto, Ontario, Canada

Location

Centre Hospitalier de l'Université de Montréal-Saint-Luc Hospital

Montreal, Quebec, H2X 3J4, Canada

Location

MUHC - McGill University

Montreal, Quebec, Canada

Location

Clinica Alemana de Santiago

Santiago, Chile

Location

Hopital Edouard Herriot

Lyon, France

Location

Evangelischen Krankenhaus

Düsseldorf, Germany

Location

Asian Institute of Gastroenterology

Hyderabad, India

Location

Università Cattolica del Sacro Cuore Policlinico A. Gemelli

Rome, 00168, Italy

Location

Erasmus Medical Center

Rotterdam, Netherlands

Location

Hospital Universitari Doctor Josep Trueta

Girona, Catalonia, Spain

Location

Related Publications (4)

• 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.

  PMID: 24801350 RESULT

• 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.

  PMID: 32417298 DERIVED

• 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.

  PMID: 31830897 DERIVED

• 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.

  PMID: 31494135 DERIVED

Related Links

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

Results Point of Contact

• Title: Jacques Devière, MD, PhD
• Organization: Hôpital Erasme

Jacques.Deviere@erasme.ulb.ac.be

(32) 0-2-555-4697.

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2009
• First Posted: November 17, 2009
• Study Start: December 1, 2009
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2017
• Last Updated: February 19, 2020
• Results First Posted: February 19, 2020

Record last verified: 2020-02

Locations

CA (3); BE (1); AU (1); FR (1); IN (1); IT (1); NL (1); ES (1); CL (1); DE (1)