A multi-center, single arm, prospective study of the WallFlex biliary partially covered stent for the palliative treatment of malignant bile duct obstruction.
- Conditions
- Malignant biliary obstructionmalignant obstruction of the biliary tract10019815
- Registration Number
- NL-OMON30737
- Lead Sponsor
- Boston Scientific Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 18
Inclusion Criteria
Inoperable extrahepatic biliary obstruction by any malignant process.
Indicated for metal stent placement for palliative treatment of biliary stricture(s) produced by malignant neoplasms.
Exclusion Criteria
Strictures that cannot be dilated enough to pass the delivery system.
Perforation of any duct within the biliary tree.
Presence of metal biliary stent.
Patients with active hepatitis.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Adequate clinical palliation of the biliary obstruction defined as absence of<br /><br>recurrent biliary obstruction within 6 months or prior to death, whichever<br /><br>comes first. Recurrent biliary obstruction will be determined by the treating<br /><br>physician based on imaging of the stent and/or cholestatic symptoms and/or<br /><br>abnormal liver function tests.</p><br>
- Secondary Outcome Measures
Name Time Method <p>1. Safety<br /><br>2. Technical success of stent placement<br /><br>3. Re-interventions<br /><br>4. Clinical symptoms of biliary obstruction<br /><br>5. Laboratory liver tests<br /><br>6. Recurrent biliary obstructions at 1 week, 2 weeks, 1 month, 3 months and 6<br /><br>months<br /><br>7. Time to recurrent biliary obstruction<br /><br>8. The possibility of stent removal during placement</p><br>