Biodegradable Biliary Stent for Post Operative Cystic Duct Leakage

June 24, 2010 updated by: Tampere University

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

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 Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Tampere, Finland, FIN-33521
        • Tampere University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Clinical healing of bile leakage
Time Frame: 1 month
1 month

Secondary Outcome Measures

Outcome Measure
Time Frame
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
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tampere University

Investigators

  • Principal Investigator: Juhani A Sand, MD, PhD, Tampere University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2006

Study Completion (Anticipated)

June 1, 2010

Study Registration Dates

First Submitted

June 27, 2007

First Submitted That Met QC Criteria

June 27, 2007

First Posted (Estimate)

June 28, 2007

Study Record Updates

Last Update Posted (Estimate)

June 28, 2010

Last Update Submitted That Met QC Criteria

June 24, 2010

Last Verified

February 1, 2009

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • R06089

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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