Cyst Clinical Trial
Official title:
Biodegradable Biliary Stent for Post Operative Cystic Duct Leakage. Pilot Study
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.
| Status | Withdrawn |
| Enrollment | 0 |
| Est. completion date | June 2010 |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Patients with confirmed post cholecystectomy cystic duct leakage requiring endoscopic treatment |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Finland | Tampere University Hospital | Tampere |
| Lead Sponsor | Collaborator |
|---|---|
| University of Tampere |
Finland,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Clinical healing of bile leakage | 1 month | ||
| Secondary | Laboratory tests for liver function, ultra sound for bile collections and bile duct diameter and abdominal plain X-ray for stent degradation | 6 months |