Biodegradable Biliary Stent for Post Operative Cystic Duct Leakage
Phase 1
Withdrawn
- Conditions
- Cyst
- Registration Number
- NCT00493675
- Lead Sponsor
- Tampere University
- Brief Summary
Endoscopic sphincterotomy and temporary stenting is a routine treatment for post cholecystectomy cystic duct leakage. The draw back is that the plastic stent need to be removed later in a second intervention. Our studies with animal models have demonstrated that biodegradable biliary stent is at least as good as conventional plastic stent to heal that kind of leakage. In this pilot study the biodegradable biliary stent is inserted endoscopically to patients with confirmed cystic duct leakage to demonstrate the efficacy in human setting.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- Patients with confirmed post cholecystectomy cystic duct leakage requiring endoscopic treatment
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Exclusion Criteria
Not provided
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Clinical healing of bile leakage 1 month
- Secondary Outcome Measures
Name Time Method Laboratory tests for liver function, ultra sound for bile collections and bile duct diameter and abdominal plain X-ray for stent degradation 6 months
Trial Locations
- Locations (1)
Tampere University Hospital
🇫🇮Tampere, Finland