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

Primary Purpose

Gall Stones

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Laser Lithotripsy
Electrohydraulic Lithotripsy
Sponsored by
The Cleveland Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gall Stones focused on measuring biliary, lithotripsy, gall stones, bile duct, Biliary stones

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cleveland Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Electrohydraulic lithotripsy

Laser Lithotripsy

Arm Description

Electrohydraulic lithotripsy: Lithotripsy will be performed using electrohydraulic method

Laser Lithotripsy: Lithotripsy will be performed using laser method

Outcomes

Primary Outcome Measures

Time
Identify which technique takes less time to completion.

Secondary Outcome Measures

Number of shocks
Comparsion between procudures of the number of shocks to fragment stones

Full Information

First Posted
December 23, 2009
Last Updated
March 28, 2017
Sponsor
The Cleveland Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT01571271
Brief Title
Electrohydraulic Versus Laser Lithotripsy for Treatment of Difficult to Remove Biliary Stones
Acronym
EHLvlaser
Official Title
Electrohydraulic Versus Laser Lithotripsy for Treatment of Difficult to Remove Biliary Stones
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Cleveland Clinic

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gall Stones
Keywords
biliary, lithotripsy, gall stones, bile duct, Biliary stones

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Electrohydraulic lithotripsy
Arm Type
Experimental
Arm Description
Electrohydraulic lithotripsy: Lithotripsy will be performed using electrohydraulic method
Arm Title
Laser Lithotripsy
Arm Type
Experimental
Arm Description
Laser Lithotripsy: Lithotripsy will be performed using laser method
Intervention Type
Procedure
Intervention Name(s)
Laser Lithotripsy
Other Intervention Name(s)
Lithotripsy
Intervention Description
Laser Lithotripsy
Intervention Type
Procedure
Intervention Name(s)
Electrohydraulic Lithotripsy
Intervention Description
Electrohydraulic Lithotripsy
Primary Outcome Measure Information:
Title
Time
Description
Identify which technique takes less time to completion.
Time Frame
Procudre duration
Secondary Outcome Measure Information:
Title
Number of shocks
Description
Comparsion between procudures of the number of shocks to fragment stones
Time Frame
Procedure duration

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mansour A. Parsi, MD
Organizational Affiliation
The Cleveland Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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