NCT00493675
Withdrawn
Phase 1
Biodegradable Biliary Stent for Post Operative Cystic Duct Leakage. Pilot Study
ConditionsCyst
Overview
- Phase
- Phase 1
- Status
- Withdrawn
- Sponsor
- Tampere University
- Locations
- 1
- Primary Endpoint
- Clinical healing of bile leakage
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients with confirmed post cholecystectomy cystic duct leakage requiring endoscopic treatment
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Clinical healing of bile leakage
Time Frame: 1 month
Secondary Outcomes
- Laboratory tests for liver function, ultra sound for bile collections and bile duct diameter and abdominal plain X-ray for stent degradation(6 months)
Investigators
Study Sites (1)
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