Cyst
Conditions
Keywords
Cystic duct leakage
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.
Interventions
PROCEDUREendoscopic bile duct stenting
Sponsors
Tampere University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with confirmed post cholecystectomy cystic duct leakage requiring endoscopic treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical healing of bile leakage | 1 month |
Secondary
| Measure | Time frame |
|---|---|
| Laboratory tests for liver function, ultra sound for bile collections and bile duct diameter and abdominal plain X-ray for stent degradation | 6 months |
Countries
Finland
Outcome results
None listed