Biodegradable Biliary Stent for Post Operative Cystic Duct Leakage

NCT ID: NCT00493675

Last Updated: 2010-06-28

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-06-30
• Study Completion Date: 2010-06-30

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.

Conditions

Cyst

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

endoscopic bile duct stenting

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tampere University

OTHER

Sponsor Role: lead

Principal Investigators

Juhani A Sand, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Tampere University Hospital

Locations

Tampere University Hospital

Tampere, , Finland

Countries

Finland

Other Identifiers

R06089

Identifier Type: -

Identifier Source: org_study_id