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

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Observational

Official Title: Prospective Evaluation of the Clinical Utility of Endoscopically-placed Self Expandable Stents

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.

Detailed Summary: same as brief summary
Sponsor: University of Florida

Current Primary Outcome: 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


Original Primary Outcome: Same as current

Current Secondary Outcome: 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


Original Secondary Outcome: Same as current

Information By: University of Florida

Dates:
Date Received: November 16, 2011
Date Started: November 2011
Date Completion:
Last Updated: June 26, 2013
Last Verified: June 2013