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

Gall Stones Clinical Trial

— EHLvlaser  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01571271
• Other study ID #: 09-168
• Status: Completed
• Phase: N/A
• First received: December 23, 2009
• Last updated: March 28, 2017
• Start date: January 2010
• Est. completion date: March 2015

Study information

• Verified date: March 2017
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Other known NCT identifiers

• NCT01039246

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Calculi
• Cholecystolithiasis
• Cholelithiasis
• Gall Stones
• Gallstones

Intervention

Procedure:
• Laser Lithotripsy
Laser Lithotripsy
• Electrohydraulic Lithotripsy
Electrohydraulic Lithotripsy

Locations

Country	Name	City	State
United States	Cleveland Clinic	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time	Identify which technique takes less time to completion.	Procudre duration
Secondary	Number of shocks	Comparsion between procudures of the number of shocks to fragment stones	Procedure duration