WallFlex Biliary Fully Covered (FC) Chronic Pancreatitis Study

Not Applicable

Completed

Interventions: Device: Commercially available Plastic Stent Per Investigator preference
Device: WallFlex™ Biliary RX Fully Covered Stent System RMV

Brief 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.

Recruitment & 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
Symptomatic bile duct stricture (defined by cholangitis or persistent jaundice for at least one month or cholestasis associated with at least 3 times normal alkaline phosphatase levels) documented at time of enrollment for naïve stricture or at the time of prior plastic stent placement in strictures that had one prior plastic stent inserted.12
Common bile duct stricture based on imaging assessment of dilatation of the common and/or intrahepatic bile ducts

Exclusion Criteria

Biliary stricture of benign etiology other than chronic pancreatitis
Prior biliary metal stent or any plastic stenting other than one plastic stent of 10 Fr or less for 6 months or fewer
Developing obstructive biliary symptoms associated with an attack of acute pancreatitis
Biliary stricture of malignant etiology
Stricture within 2 cm of common bile duct bifurcation
Known bile duct fistula or leak
Subjects for whom endoscopic techniques are contraindicated
Known sensitivity to any components of the stent or delivery system
Symptomatic duodenal stenosis (with gastric stasis)
Participation in another investigational study within 90 days prior to consent
Investigator Discretion

Arm && Interventions

Group	Intervention	Description
Plastic Stents	Commercially available Plastic Stent Per Investigator preference	Plastic stents per Investigator preference are being evaluated for treatment of benign biliary strictures secondary to chronic pancreatitis.
Metal stents	WallFlex™ Biliary RX Fully Covered Stent System RMV	The WallFlex Biliary Fully Covered Stent System is being evaluated for treatment of benign biliary strictures secondary to chronic pancreatitis.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Stricture Resolution	After 12-month stenting period through 24 month follow-up (approximately 12 months)	Stricture resolution defined as absence of re-stenting after the 12-month stenting period, and 24 months serum alkaline phosphatase level not exceeding twice the level at the end of stenting period.

Secondary Outcome Measures

Name	Time	Method
Number of Stents Placed	Initial stent placement procedure to 24 month follow-up	Number of stents placed throughout study to 24 month follow-up
Number of ERCP Procedures Through 24 Months After Initial Stent Placement.	Initial stent placement procedure to 24 month follow-up	The number of endoscopic retrograde cholangiopancreatography (ERCP) procedures through 24 months, after initial stent placement.
Serious Adverse Events Related to the Device or Procedure	Initial stent placement procedure to 24 month follow-up	Device or procedure related serious adverse events from the initial stent placement procedure to the 24 month follow-up.
Ability to Deploy Stent(s) in Satisfactory Position (Technical Success)	Initial stent placement procedure	Technical success defined as the ability to deploy the stent(s) in satisfactory position during initial stent placement procedure.
Length of Stent Placement and Removal Procedures	Initial stent placement procedure to 24 month follow-up	Length of stent placement procedures and stent removal procedures.

Locations (14): Westmead Hospital
🇦🇺
Westmead, New South Wales, Australia
Royal Prince Alfred Medical Center
🇦🇺
Newtown, New South Wales, Australia
Allgemeines Krankenhaus AKH
🇦🇹
Vienna, Austria
Erasme Hospital
🇧🇪
Brussels, Belgium
Hopital Edouard Herriot
🇫🇷
Lyon, France
Evangelisches Krankenhaus Dusseldorf
🇩🇪
Dusseldorf, Germany
Asian Institute of Gastroenterology
🇮🇳
Hyderabad, India
Azienda Ospedaliera Universitaria Integrata di Verona
🇮🇹
Verona, VR, Italy
Policlinico Universitario Agostino Gemelli
🇮🇹
Rome, Italy
Erasmus Medical Center
🇳🇱
Rotterdam, CE, Netherlands
Karolinska Universitets Sjukhuset
🇸🇪
Stockholm, Sweden
UZ Gasthuisberg
🇧🇪
Leuven, Belgium
CHUM - Hopital Saint-Luc
🇨🇦
Montreal, Quebec, Canada
Prince of Wales Hospital
🇭🇰
Shatin, New Territories, Hong Kong