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

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.

Study Overview

• Status: Completed
• Conditions: Gall Stones
• Intervention / Treatment: Procedure: Electrohydraulic Lithotripsy; Procedure: Laser Lithotripsy

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: Lithotripsy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time	Identify which technique takes less time to completion.	Procudre duration

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of shocks	Comparsion between procudures of the number of shocks to fragment stones	Procedure duration

Collaborators and Investigators

• Sponsor: The Cleveland Clinic
• Investigators: Principal Investigator: Mansour A. Parsi, MD, The Cleveland Clinic

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (Actual): March 1, 2015
• Study Completion (Actual): March 1, 2015

Study Registration Dates

• First Submitted: December 23, 2009
• First Submitted That Met QC Criteria: April 3, 2012
• First Posted (Estimate): April 5, 2012

Study Record Updates

• Last Update Posted (Actual): March 30, 2017
• Last Update Submitted That Met QC Criteria: March 28, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: biliary; lithotripsy; gall stones; bile duct; Biliary stones
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathological Conditions, Anatomical; Gallbladder Diseases; Biliary Tract Diseases; Calculi; Gallstones; Cholelithiasis; Cholecystolithiasis
• Other Study ID Numbers: 09-168

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No