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

This study has been withdrawn prior to enrollment.
(no subjects were found who met criteria)
Sponsor:
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT01475864
First received: November 16, 2011
Last updated: June 26, 2013
Last verified: June 2013
  Purpose

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 Intervention
Choledocholithiasis
Procedure: ERCP with metal stent

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Prospective Evaluation of the Clinical Utility of Endoscopically-placed Self Expandable Stents

Resource links provided by NLM:


Further study details as provided by University of Florida:

Primary Outcome Measures:
  • complete biliary stone clearance [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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:
  • other techniques used for stone clearance [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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


Enrollment: 0
Study Start Date: November 2011
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

Detailed Description:

same as brief summary

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01475864

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

No publications provided

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT01475864     History of Changes
Other Study ID Numbers: Biliary stone
Study First Received: November 16, 2011
Last Updated: June 26, 2013
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on November 25, 2014