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

NeuroTherapia, Inc.

Status: Completed

Conditions: Gall Stones

Treatments: Procedure: Electrohydraulic Lithotripsy; Procedure: Laser Lithotripsy

Study type: Interventional

Funder types: Other

Identifiers

NCT01571271

09-168

Details and patient eligibility

About

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.

Full description

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

Enrollment: 25 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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25 participants in 2 patient groups

Electrohydraulic lithotripsy

Experimental group

Description:

Electrohydraulic lithotripsy: Lithotripsy will be performed using electrohydraulic method

Treatment:

Procedure: Electrohydraulic Lithotripsy

Laser Lithotripsy

Experimental group

Description:

Laser Lithotripsy: Lithotripsy will be performed using laser method

Treatment:

Procedure: Laser Lithotripsy