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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by The Cleveland Clinic
Sponsor:
Information provided by (Responsible Party):
The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT01571271
First received: December 23, 2009
Last updated: July 29, 2013
Last verified: July 2013

December 23, 2009
July 29, 2013
January 2010
December 2013   (final data collection date for primary outcome measure)
Time [ Time Frame: Procudre duration ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: Yes ]
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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Gall Stones
Procedure: Laser Lithotripsy
Laser Lithotripsy
Other Name: Lithotripsy
Experimental: Electrohydraulic lithotripsy
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.
 
Recruiting
200
December 2013
December 2013   (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
Both
18 Years and older
No
Contact: Mansour Parsi, MD 216 444 6284 parsim@ccf.org
United States
 
NCT01571271
09-168
No
The Cleveland Clinic
The Cleveland Clinic
Not Provided
Principal Investigator: Mansour A. Parsi, MD The Cleveland Clinic
The Cleveland Clinic
July 2013

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