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

NCT ID: NCT01571271

Last Updated: 2017-03-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2015-03-31

Brief Summary

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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

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

Conditions

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Gall Stones

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Electrohydraulic lithotripsy

Electrohydraulic lithotripsy: Lithotripsy will be performed using electrohydraulic method

Group Type EXPERIMENTAL

Electrohydraulic Lithotripsy

Intervention Type PROCEDURE

Electrohydraulic Lithotripsy

Laser Lithotripsy

Laser Lithotripsy: Lithotripsy will be performed using laser method

Group Type EXPERIMENTAL

Laser Lithotripsy

Intervention Type PROCEDURE

Laser Lithotripsy

Interventions

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Laser Lithotripsy

Laser Lithotripsy

Intervention Type PROCEDURE

Electrohydraulic Lithotripsy

Electrohydraulic Lithotripsy

Intervention Type PROCEDURE

Other Intervention Names

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Lithotripsy

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Cleveland Clinic

OTHER

Sponsor Role lead

Responsible Party

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Mansour Parsi, MD

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mansour A. Parsi, MD

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Locations

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Cleveland Clinic

Cleveland, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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09-168

Identifier Type: -

Identifier Source: org_study_id

NCT01039246

Identifier Type: -

Identifier Source: nct_alias

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