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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 172
- Locations
- 14
- Primary Endpoint
- Number of Participants With Stricture Resolution
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Metal stents
The WallFlex Biliary Fully Covered Stent System is being evaluated for treatment of benign biliary strictures secondary to chronic pancreatitis.
Intervention: WallFlex™ Biliary RX Fully Covered Stent System RMV (Device)
Plastic Stents
Plastic stents per Investigator preference are being evaluated for treatment of benign biliary strictures secondary to chronic pancreatitis.
Intervention: Commercially available Plastic Stent Per Investigator preference (Device)
Outcomes
Primary Outcomes
Number of Participants With Stricture Resolution
Time Frame: 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 Outcomes
- Number of ERCP Procedures Through 24 Months After Initial Stent Placement.(Initial stent placement procedure to 24 month follow-up)
- Number of Stents Placed(Initial stent placement procedure to 24 month follow-up)
- Serious Adverse Events Related to the Device or Procedure(Initial stent placement procedure to 24 month follow-up)
- Ability to Deploy Stent(s) in Satisfactory Position (Technical Success)(Initial stent placement procedure)
- Length of Stent Placement and Removal Procedures(Initial stent placement procedure to 24 month follow-up)