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
- benign blockage of bile duct due to chronic pancreatitis or benign biliary obstruction due to chronic pancreatitis1001800810014710
- Registration Number
- NL-OMON39165
- Lead Sponsor
- Boston Scientific Cooperation International
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 25
• 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
• 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
• Investigator Discretion
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary Endpoint: Stricture resolution at 24 months.<br /><br><br /><br>Stricture resolution at 24 months is defined by the following two criteria<br /><br>being met:<br /><br>• Absence of re-stenting after the per-protocol stenting period through the 24<br /><br>month visit<br /><br>• Absence of cholestasis at the 24 month visit, defined as alkaline phosphatase<br /><br>level not exceeding 2 times the level at completion of the per-protocol<br /><br>stenting period </p><br>
- Secondary Outcome Measures
Name Time Method