NCT01571271

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 23, 2009

Completed
9 days until next milestone

Study Start

First participant enrolled

January 1, 2010

Completed
2.3 years until next milestone

First Posted

Study publicly available on registry

April 5, 2012

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

March 30, 2017

Status Verified

March 1, 2017

Enrollment Period

5.2 years

First QC Date

December 23, 2009

Last Update Submit

March 28, 2017

Conditions

Gall Stones

Keywords

biliarylithotripsygall stonesbile ductBiliary stones

Outcome Measures

Primary Outcomes (1)

  • Time

    Identify which technique takes less time to completion.

    Procudre duration

Secondary Outcomes (1)

  • Number of shocks

    Procedure duration

Study Arms (2)

Electrohydraulic lithotripsy

EXPERIMENTAL

Electrohydraulic lithotripsy: Lithotripsy will be performed using electrohydraulic method

Procedure: Electrohydraulic Lithotripsy

Laser Lithotripsy

EXPERIMENTAL

Laser Lithotripsy: Lithotripsy will be performed using laser method

Procedure: Laser Lithotripsy

Interventions

Laser LithotripsyPROCEDURE

Laser Lithotripsy

Also known as: Lithotripsy
Laser Lithotripsy
Electrohydraulic LithotripsyPROCEDURE

Electrohydraulic Lithotripsy

Electrohydraulic lithotripsy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • or more gall stones in bile duct which cannot be removed using conventional methods (must be fragmented)
  • Adults able to provide informed consent

You may not qualify if:

  • Pregnancy or lactation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

GallstonesCholecystolithiasis

Interventions

Lithotripsy, LaserLithotripsy

Condition Hierarchy (Ancestors)

CholelithiasisBiliary Tract DiseasesDigestive System DiseasesGallbladder DiseasesCalculiPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Laser TherapyTherapeuticsAblation TechniquesSurgical Procedures, OperativeUltrasonic Surgical Procedures

Study Officials

  • Mansour A. Parsi, MD

    The Cleveland Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

December 23, 2009

First Posted

April 5, 2012

Study Start

January 1, 2010

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

March 30, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)