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Prospective Evaluation of the Covered Self-expandable Metal Stents (CSEMS) for Incomplete Biliary Stone Clearance

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ClinicalTrials.gov Identifier: NCT01475864
Recruitment Status : Withdrawn (no subjects were found who met criteria)
First Posted : November 21, 2011
Last Update Posted : June 27, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The current standard of care for bile duct stone are endoscopic sphincterotomy and stone extraction. Placement of plastic stents is an option for incomplete biliary stone clearance. This study will use the CSEMS in patients with complex biliary stones who failed stone extraction as they have the advantage of large stent diameter. CSEMS may offer a temporizing measure that allows more successful subsequent stone clearance. However, their use in benign condition has been limited especially for biliary stone removal. The purpose of this study is to determine the feasibility, safety, easy removability, stent-stone formation rate, and migration rate of CSEMS for complex biliary stones.

Condition or disease Intervention/treatment
Choledocholithiasis Procedure: ERCP with metal stent

Detailed Description:
same as brief summary

Study Design

Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Prospective Evaluation of the Clinical Utility of Endoscopically-placed Self Expandable Stents
Study Start Date : November 2011
Primary Completion Date : June 2013
Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Gallstones
U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
Incomplete biliary stone extraction. Procedure: ERCP with metal stent
ERCP will be used so that a metal stent can be placed to facilitate the removal of the biliary stone
Other Name: see above information


Outcome Measures

Primary Outcome Measures :
  1. complete biliary stone clearance [ Time Frame: 12 months ]
    This is an observational study where the ERCP being done is part of the standard of care for choledocholithiasis. There are no study interventions


Secondary Outcome Measures :
  1. other techniques used for stone clearance [ Time Frame: 12 months ]
    This will include the number of ERCP's needed to achive the complete biliary stone clearance, Use of mechanical Lithotripsy, use of cholangioscopy, procedure duration and any adverse events safety


Eligibility Criteria

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
Sampling Method:   Non-Probability Sample
Study Population
Those patients who have a biliary stone that has not been removed by standard medical care.
Criteria

Inclusion Criteria:

  • 18 years and older
  • Bilary stone unable to be extracted with balloon, basket, large balloon dilation of the ampulla or mechanical lithotripsy.
  • Stone can be bridged by the metal stent
  • Subject must be able to give informed consent.

Exclusion Criteria:

  • Any contraindication to ERCP
  • Patient refuses consent for the study.
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): NCT01475864


Sponsors and Collaborators
University of Florida
Investigators
Principal Investigator: Peter V Draganov, MD University of Florida
More Information

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT01475864     History of Changes
Other Study ID Numbers: Biliary stone
First Posted: November 21, 2011    Key Record Dates
Last Update Posted: June 27, 2013
Last Verified: June 2013

Keywords provided by University of Florida:
Choledocholithiasis
metal stents
biliary duct stent

Additional relevant MeSH terms:
Choledocholithiasis
Common Bile Duct Diseases
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases
Cholelithiasis