Back to resultsFlexible urétéroscopy Versus Extracorporeal Shockwave Lithotripsy in Renal Calculi (CALIX-1)
Primary Purpose
Extracorporeal Shockwave Lithotripsy, Flexible Ureteroscopy
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
flexible ureteroscopy
extracorporeal shockwave lithotripsy
Sponsored by
About this trial
This is an interventional treatment trial for Extracorporeal Shockwave Lithotripsy, Flexible Ureteroscopy focused on measuring stone, calculi, kidney, renal treatment, flexible ureteroscopy, extracoporeal shockwave lithotripsy, retrograde intra renal surgery
Eligibility Criteria
Inclusion Criteria:
- Patient with 5 to 20 mm renal stone
- Age ≥ 18 years old
- Patient agreement signed
- BMI < 35
- Contraception
Exclusion Criteria:
- Pregnancy
- Severe musculoskeletal deformities
- Renal artery or aorta aneurysm
- Pacemaker
- Anesthesia contra indication
- Psychiatric trouble or law protection
Sites / Locations
- Service d'urologie, Hôpital Edouard Herriot
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Extracorporeal shockwave lithotripsy
Flexible ureteroscopy
Arm Description
stone treatment using electroconductive technology
intra renal retrograde surgery with or without laser and stone extraction
Outcomes
Primary Outcome Measures
Stone free rate
Rate of stone free patient or patient with residual fragment ≤ 3 mm, 3 months after the treatment evaluated, will be compare. This outcome is measured with a tomodensitometry and compares with pre treatment exams.
Secondary Outcome Measures
Stone free rate in weight's sub group
Each arm wil be divise in 3 sub group based on body mass index (20 to 25, 25 to 30, 30 to 35). We'll compare rate of efficacity in each sub group
Stone free rate in sub group depending on stone diameters
Each arm wil be divise in 3 sub group based on calculi diameter (5 to 10mm, 10 to 15 and 15 to 20). We'll compare rate of efficacity in each sub group
Secondary procedure rate
In each arm will be evaluate rate of secondary procedure needed to have the best stone free rate
Serious and non serious adverse events
In each arm will be evaluate rate of adverse event, type, severity.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01604304
Brief Title
Flexible urétéroscopy Versus Extracorporeal Shockwave Lithotripsy in Renal Calculi
Acronym
CALIX-1
Official Title
Flexible urétéroscopy Versus Extracorporeal Shockwave Lithotripsy in 5 to 20 mm Renal Calculi, Efficacity Prospective Randomized Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
February 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Flexible ureteroscopy is a recent procedure to treat renal stone. Extracorporeal shockwave lithotripsy was the gold standard treatment for calculi between 5 and 20 mm. In literature, the two procedures are available to treat these stones with a good stone free rate. There is no prospective randomized study comparing these two treatments. Our study will define with a good level of evidence which technique is the best with regard to the stone free rate, secondary procedure rate and adverse effect.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Extracorporeal Shockwave Lithotripsy, Flexible Ureteroscopy
Keywords
stone, calculi, kidney, renal treatment, flexible ureteroscopy, extracoporeal shockwave lithotripsy, retrograde intra renal surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Extracorporeal shockwave lithotripsy
Arm Type
Active Comparator
Arm Description
stone treatment using electroconductive technology
Arm Title
Flexible ureteroscopy
Arm Type
Active Comparator
Arm Description
intra renal retrograde surgery with or without laser and stone extraction
Intervention Type
Procedure
Intervention Name(s)
flexible ureteroscopy
Intervention Description
Flexible ureteroscopy will be use for 120 min max to treat renal stone. Laser, access sheath, baskets can be use to perform the technique.
Intervention Type
Procedure
Intervention Name(s)
extracorporeal shockwave lithotripsy
Intervention Description
The lithotriptor is use with 1,1 Hz frequency and stop when patient get 1000 joules of energy or if there is a problem with tolerance of this treatment or if stone is broken
Primary Outcome Measure Information:
Title
Stone free rate
Description
Rate of stone free patient or patient with residual fragment ≤ 3 mm, 3 months after the treatment evaluated, will be compare. This outcome is measured with a tomodensitometry and compares with pre treatment exams.
Time Frame
Three months
Secondary Outcome Measure Information:
Title
Stone free rate in weight's sub group
Description
Each arm wil be divise in 3 sub group based on body mass index (20 to 25, 25 to 30, 30 to 35). We'll compare rate of efficacity in each sub group
Time Frame
3 months
Title
Stone free rate in sub group depending on stone diameters
Description
Each arm wil be divise in 3 sub group based on calculi diameter (5 to 10mm, 10 to 15 and 15 to 20). We'll compare rate of efficacity in each sub group
Time Frame
3 months
Title
Secondary procedure rate
Description
In each arm will be evaluate rate of secondary procedure needed to have the best stone free rate
Time Frame
3 months
Title
Serious and non serious adverse events
Description
In each arm will be evaluate rate of adverse event, type, severity.
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient with 5 to 20 mm renal stone
Age ≥ 18 years old
Patient agreement signed
BMI < 35
Contraception
Exclusion Criteria:
Pregnancy
Severe musculoskeletal deformities
Renal artery or aorta aneurysm
Pacemaker
Anesthesia contra indication
Psychiatric trouble or law protection
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xavier Martin, PhD
Organizational Affiliation
Hospices Civils de Lyon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Service d'urologie, Hôpital Edouard Herriot
City
Lyon
ZIP/Postal Code
69 003
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
25640027
Citation
Ravier E, Abid N, Ruffion A, Fassi-Fehri H, Buron C, Ganne C, Mallet A, Martin X. [Effectiveness of flexible ureteroscopy versus extracorporeal shock wave lithotripsy for kidney stones treatment]. Prog Urol. 2015 Apr;25(5):233-9. doi: 10.1016/j.purol.2015.01.005. Epub 2015 Jan 29. French.
Results Reference
result
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Flexible urétéroscopy Versus Extracorporeal Shockwave Lithotripsy in Renal Calculi
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