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Clinical Trial 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.


Clinical Trial Description

n/a


Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00493675
Study type Interventional
Source University of Tampere
Contact
Status Withdrawn
Phase Phase 1
Start date June 2006
Completion date June 2010