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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
  Purpose
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 Intervention
Gall Stones Procedure: Laser Lithotripsy Procedure: Electrohydraulic Lithotripsy

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Mansour Parsi, MD, The Cleveland Clinic:

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


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


Enrollment: 25
Study Start Date: January 2010
Study Completion Date: March 2015
Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

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
Criteria

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
  Contacts and Locations
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


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

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 Submitted: December 23, 2009
First Posted: April 5, 2012
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:
biliary
lithotripsy
gall stones
bile duct
Biliary stones

Additional relevant MeSH terms:
Calculi
Cholelithiasis
Cholecystolithiasis
Gallstones
Pathological Conditions, Anatomical
Biliary Tract Diseases
Digestive System Diseases
Gallbladder Diseases