WallFlex Biliary Fully Covered (FC) Benign Stricture Study

Biliary Stricture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01014390
• Other study ID #: CDM 00027550
• Status: Completed
• Phase: Phase 3
• Start date: December 2009
• Est. completion date: November 2017

Study information

• Verified date: February 2020
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 187
• Est. completion date: November 2017
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Biliary Stricture
• Cholestasis
• Constriction, Pathologic

Intervention

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.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Countries where clinical trial is conducted

Australia,  Austria,  Belgium,  Canada,  Chile,  France,  Germany,  India,  Italy,  Netherlands,  Spain, 

References & Publications (1)

Devière J, Nageshwar Reddy D, Püspök A, Ponchon T, Bruno MJ, Bourke MJ, Neuhaus H, Roy A, González-Huix Lladó F, Barkun AN, Kortan PP, Navarrete C, Peetermans J, Blero D, Lakhtakia S, Dolak W, Lepilliez V, Poley JW, Tringali A, Costamagna G; Benign Biliar — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

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