NCT00852072|Completed
Randomized Trial for Extraction of Difficult Bile Duct Stones
A Randomized Trial to Identify the Optimal Approach for Management of Difficult Bile Duct Stones
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A Randomized Trial to Identify the Optimal Approach for Management of Difficult Bile Duct Stones
Sponsor study identifier
interventional
66
1 country
1
Study Start
March 2016
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
October 31, 2018
Actual (reported)Study Completion
December 31, 2018
Actual (reported)Removal of bile duct stones can be challenging at ERCP, particularly, when the size of the stone is at least 1.2cm, and may require more than one ERCP session. Various techniques for removal of difficult bile duct stones include using a balloon to enlarge the opening of the bile duct (large balloon sphincteroplasty), mechanical lithotripsy or single-operator cholangioscopy guided laser lithotripsy techniques. There are currently no randomized trials comparing laser lithotripsy and sphincteroplasty techniques for the removal of difficult bile duct stones and the aim of this randomized trial is to determine which technique is superior in the removal of difficult bile duct stones.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2018
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 25, 2009
Actual (reported)February 26, 2009
Actual (reported)March 2016
Date type not reportedThis date has not been verified as actual or estimated.
October 31, 2018
Actual (reported)December 31, 2018
Actual (reported)Treatment success defined as the ability to clear the bile duct of all stones in one ERCP session using either the single-operator cholangioscopy-guided laser lithotripsy-based technique or large balloon sphincteroplasty-based technique
Treatment success defined as the ability to clear the bile duct of all stones in one ERCP session
24 months
Compare the safety of large balloon sphincteroplasty and single-operator cholangioscopy-guided laser lithotripsy techniques
24 months
Compare the costs of large balloon sphincteroplasty and single-operator cholangioscopy-guided laser lithotripsy techniques
24 months
Compare the need for repeat interventions in large balloon sphincteroplasty and single-operator cholangioscopy-guided laser lithotripsy techniques
24 months
Ability to clear the bile duct of all stones in one ERCP session using laser lithotripsy-based technique, including use of mechanical lithotripsy
Ability to clear the bile duct of all stones in one ERCP session using large balloon sphincteroplasty-based technique, including use of mechanical lithotripsy
Ability to clear the bile duct of all stones in one ERCP session using laser lithotripsy-based technique, including use of mechanical lithotripsy
Ability to clear the bile duct of all stones in one ERCP session using large balloon sphincteroplasty-based technique, including use of mechanical lithotripsy
Florida Hospital
Orlando, Florida, 32803, United States
Bang JY, Sutton B, Navaneethan U, Hawes R, Varadarajulu S. Efficacy of Single-Operator Cholangioscopy-Guided Lithotripsy Compared With Large Balloon Sphincteroplasty in Management of Difficult Bile Duct Stones in a Randomized Trial. Clin Gastroenterol Hepatol. 2020 Sep;18(10):2349-2356.e3. doi: 10.1016/j.cgh.2020.02.003. Epub 2020 Feb 10.
Shyam Varadarajulu, MD
AdventHealth
66 participants (actual enrollment reported by the registry).
First Submitted
February 25, 2009
First Posted
February 26, 2009
Study Start
March 2016
Date type not reportedThis date has not been verified as actual or estimated.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
October 31, 2018
Actual (reported)Study Completion
December 31, 2018
Actual (reported)Last Updated
October 10, 2019
Record last verified: 2019-10
A manuscript will be developed when the study is complete.
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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