NL-OMON39165
Completed
Not Applicable
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 - WallFlex Biliary FC Chronic Pancreatitis RCT
Boston Scientific Cooperation International0 sites25 target enrollmentTBD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Boston Scientific Cooperation International
- Enrollment
- 25
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
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 naive stricture or at the time of prior plastic stent placement \- in strictures that had one prior plastic stent inserted.
- •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 10Fr 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
Outcomes
Primary Outcomes
Not specified
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