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Biodegradable Biliary Stent for Post Operative Cystic Duct Leakage

This study has been withdrawn prior to enrollment.
(Difficulties in getting suitable applicators for biodegradable stents.)
Sponsor:
Information provided by:
University of Tampere
ClinicalTrials.gov Identifier:
NCT00493675
First received: June 27, 2007
Last updated: June 24, 2010
Last verified: February 2009
History of Changes
  Purpose

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.


Condition Intervention Phase
Cyst
 Procedure: endoscopic bile duct stenting
 Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Biodegradable Biliary Stent for Post Operative Cystic Duct Leakage. Pilot Study

Resource links provided by NLM:

MedlinePlus related topics: Endoscopy
U.S. FDA Resources

Further study details as provided by University of Tampere:

Primary Outcome Measures:
  • Clinical healing of bile leakage [ Time Frame: 1 month ]

Secondary Outcome Measures:
  • Laboratory tests for liver function, ultra sound for bile collections and bile duct diameter and abdominal plain X-ray for stent degradation [ Time Frame: 6 months ]

Study Start Date: June 2006
Estimated Study Completion Date: June 2010
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with confirmed post cholecystectomy cystic duct leakage requiring endoscopic treatment
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00493675

Locations
Finland
Tampere University Hospital
Tampere, Finland, FIN-33521
Sponsors and Collaborators
University of Tampere
Investigators
Principal Investigator: Juhani A Sand, MD, PhD Tampere University Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00493675     History of Changes
Other Study ID Numbers: R06089
Study First Received: June 27, 2007
Last Updated: June 24, 2010
Health Authority: Finland: Terveydenhuollon oikeusturvakeskus (National Authority for Medicolegal Affairs)

Keywords provided by University of Tampere:
Cystic duct leakage

ClinicalTrials.gov processed this record on May 16, 2013