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Clinical Trials/NCT00493675
NCT00493675
Withdrawn
Phase 1

Biodegradable Biliary Stent for Post Operative Cystic Duct Leakage. Pilot Study

Tampere University1 site in 1 countryStarted: June 2006Last updated:
ConditionsCyst

Overview

Phase
Phase 1
Status
Withdrawn
Locations
1
Primary Endpoint
Clinical healing of bile leakage

Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Clinical healing of bile leakage

Time Frame: 1 month

Secondary Outcomes

  • Laboratory tests for liver function, ultra sound for bile collections and bile duct diameter and abdominal plain X-ray for stent degradation(6 months)

Investigators

Sponsor Class
Other

Study Sites (1)

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