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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This study has been withdrawn prior to enrollment.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:
ClinicalTrials.gov Identifier:
NCT00493675
First Posted: June 28, 2007
Last Update Posted: June 28, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of Tampere
  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: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Biodegradable Biliary Stent for Post Operative Cystic Duct Leakage. Pilot Study

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with confirmed post cholecystectomy cystic duct leakage requiring endoscopic treatment
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00493675     History of Changes
Other Study ID Numbers: R06089
First Submitted: June 27, 2007
First Posted: June 28, 2007
Last Update Posted: June 28, 2010
Last Verified: February 2009

Keywords provided by University of Tampere:
Cystic duct leakage