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Electrohydraulic Versus Laser Lithotripsy for Treatment of Difficult to Remove Biliary Stones (EHLvlaser)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01571271
First Posted: April 5, 2012
Last Update Posted: March 30, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Mansour Parsi, MD, The Cleveland Clinic
December 23, 2009
April 5, 2012
March 30, 2017
January 2010
March 2015   (Final data collection date for primary outcome measure)
Time [ Time Frame: Procudre duration ]
Identify which technique takes less time to completion.
Same as current
Complete list of historical versions of study NCT01571271 on ClinicalTrials.gov Archive Site
Number of shocks [ Time Frame: Procedure duration ]
Comparsion between procudures of the number of shocks to fragment stones
Same as current
Not Provided
Not Provided
 
Electrohydraulic Versus Laser Lithotripsy for Treatment of Difficult to Remove Biliary Stones
Electrohydraulic Versus Laser Lithotripsy for Treatment of Difficult to Remove Biliary Stones
Bile duct stones that can't be removed by conventional means can often be removed after fragmentation by shock waves (lithotripsy). The shock waves that are used for fragmentation of these stones are generated by electric sparks (electrohydraulic lithotripsy) or laser (laser lithotripsy). Although both techniques have been used for many years, there are no studies comparing the efficacy of the two. The purpose of this study is to find out which technique is more effective.
Procedures will be considered standard of care; patients or insurance companies will be billed as it is standard of care.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Gall Stones
  • Procedure: Laser Lithotripsy
    Laser Lithotripsy
    Other Name: Lithotripsy
  • Procedure: Electrohydraulic Lithotripsy
    Electrohydraulic Lithotripsy
  • Experimental: Electrohydraulic lithotripsy
    Electrohydraulic lithotripsy: Lithotripsy will be performed using electrohydraulic method
    Intervention: Procedure: Electrohydraulic Lithotripsy
  • Experimental: Laser Lithotripsy
    Laser Lithotripsy: Lithotripsy will be performed using laser method
    Intervention: Procedure: Laser Lithotripsy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
25
March 2015
March 2015   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • 1 or more gall stones in bile duct which cannot be removed using conventional methods (must be fragmented)
  • Adults able to provide informed consent

Exclusion Criteria:

  • Pregnancy or lactation
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01571271
09-168
No
Not Provided
Plan to Share IPD: No
Mansour Parsi, MD, The Cleveland Clinic
The Cleveland Clinic
Not Provided
Principal Investigator: Mansour A. Parsi, MD The Cleveland Clinic
The Cleveland Clinic
March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP