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Study Status: Withdrawn
Recruit Status: Withdrawn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 ]
Original Primary Outcome: Same as current
Current Secondary Outcome: other techniques used for stone clearance [ Time Frame: 12 months ]
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