NCT01543256

WallFlex Biliary Fully Covered (FC) Chronic Pancreatitis Study

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 172 (actual)
• Sponsor: Boston Scientific Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Biliary Stricture

Interventions

Type	Name	Description
DEVICE	WallFlex™ Biliary RX Fully Covered Stent System RMV	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")
DEVICE	Commercially available Plastic Stent Per Investigator preference	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.

Timeline

• Start date: 2012-09-18
• Primary completion: 2020-09-21
• Completion: 2020-09-21
• First posted: 2012-03-02
• Last updated: 2023-01-09
• Results posted: 2023-01-09

Locations

14 sites across 11 countries: Australia, Austria, Belgium, Canada, France, Germany, Hong Kong, India, Italy, Netherlands, Sweden