WallFlex Biliary Fully Covered (FC) Chronic Pancreatitis Study

Study Overview
=================
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.

Official Title
-----------------
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

Conditions
-----------------
Biliary Stricture

Intervention / Treatment
-----------------
* Device: WallFlex™ Biliary RX Fully Covered Stent System RMV
* Device: Commercially available Plastic Stent Per Investigator preference


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Metal stents<br>The WallFlex Biliary Fully Covered Stent System is being evaluated for treatment of benign biliary strictures secondary to chronic pancreatitis. | Device: WallFlex™ Biliary RX Fully Covered Stent System RMV<br>* 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)<br>|
| Active Comparator: Plastic Stents<br>Plastic stents per Investigator preference are being evaluated for treatment of benign biliary strictures secondary to chronic pancreatitis. | Device: Commercially available Plastic Stent Per Investigator preference<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Stricture Resolution | 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. | After 12-month stenting period through 24 month follow-up (approximately 12 months) | 

Secondary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
benign biliary strictures secondary to chronic pancreatitis