Flexible urétéroscopy Versus Extracorporeal Shockwave Lithotripsy in Renal Calculi

Study Overview
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Brief Summary
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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.

Official Title
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Flexible urétéroscopy Versus Extracorporeal Shockwave Lithotripsy in 5 to 20 mm Renal Calculi, Efficacity Prospective Randomized Trial

Conditions
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Extracorporeal Shockwave Lithotripsy, Flexible Ureteroscopy

Intervention / Treatment
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* Procedure: flexible ureteroscopy
* Procedure: extracorporeal shockwave lithotripsy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Extracorporeal shockwave lithotripsy<br>stone treatment using electroconductive technology | Procedure: extracorporeal shockwave lithotripsy<br>* 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<br>|
| Active Comparator: Flexible ureteroscopy<br>intra renal retrograde surgery with or without laser and stone extraction | Procedure: flexible ureteroscopy<br>* Flexible ureteroscopy will be use for 120 min max to treat renal stone. Laser, access sheath, baskets can be use to perform the technique.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Three months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 3 months | 
| 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 | 3 months | 
| Secondary procedure rate | In each arm will be evaluate rate of secondary procedure needed to have the best stone free rate | 3 months | 
| Serious and non serious adverse events | In each arm will be evaluate rate of adverse event, type, severity. | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stone, calculi, kidney, renal treatment, flexible ureteroscopy, extracoporeal shockwave lithotripsy, retrograde intra renal surgery