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

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ClinicalTrials.gov Identifier: NCT01571271
Recruitment Status : Completed
First Posted : April 5, 2012
Last Update Posted : March 30, 2017
Information provided by (Responsible Party):
Mansour Parsi, MD, The Cleveland Clinic

Brief Summary:
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.

Condition or disease Intervention/treatment
Gall Stones Procedure: Laser Lithotripsy Procedure: Electrohydraulic Lithotripsy

Detailed Description:
Procedures will be considered standard of care; patients or insurance companies will be billed as it is standard of care.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Electrohydraulic Versus Laser Lithotripsy for Treatment of Difficult to Remove Biliary Stones
Study Start Date : January 2010
Primary Completion Date : March 2015
Study Completion Date : March 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Gallstones
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Electrohydraulic lithotripsy
Electrohydraulic lithotripsy: Lithotripsy will be performed using electrohydraulic method
Procedure: Electrohydraulic Lithotripsy
Electrohydraulic Lithotripsy
Experimental: Laser Lithotripsy
Laser Lithotripsy: Lithotripsy will be performed using laser method
Procedure: Laser Lithotripsy
Laser Lithotripsy
Other Name: Lithotripsy

Primary Outcome Measures :
  1. Time [ Time Frame: Procudre duration ]
    Identify which technique takes less time to completion.

Secondary Outcome Measures :
  1. Number of shocks [ Time Frame: Procedure duration ]
    Comparsion between procudures of the number of shocks to fragment stones

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01571271

United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
The Cleveland Clinic
Principal Investigator: Mansour A. Parsi, MD The Cleveland Clinic

Responsible Party: Mansour Parsi, MD, MD, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT01571271     History of Changes
Obsolete Identifiers: NCT01039246
Other Study ID Numbers: 09-168
First Posted: April 5, 2012    Key Record Dates
Last Update Posted: March 30, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Mansour Parsi, MD, The Cleveland Clinic:
gall stones
bile duct
Biliary stones

Additional relevant MeSH terms:
Pathological Conditions, Anatomical
Biliary Tract Diseases
Digestive System Diseases
Gallbladder Diseases