Biodegradable Biliary Stent for Post Operative Cystic Duct Leakage

Tampere University

Status and phase: Withdrawn; Phase 1

Conditions: Cyst

Treatments: Procedure: endoscopic bile duct stenting

Study type: Interventional

Funder types: Other

Identifiers

NCT00493675

R06089

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Patients with confirmed post cholecystectomy cystic duct leakage requiring endoscopic treatment

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)