Extracorporeal Shockwave Lithotripsy, Flexible Ureteroscopy
Conditions
Keywords
stone, calculi, kidney, renal treatment, flexible ureteroscopy, extracoporeal shockwave lithotripsy, retrograde intra renal surgery
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.
Interventions
PROCEDUREflexible ureteroscopy
Flexible ureteroscopy will be use for 120 min max to treat renal stone. Laser, access sheath, baskets can be use to perform the technique.
PROCEDUREextracorporeal shockwave lithotripsy
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
Sponsors
Hospices Civils de Lyon
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Stone free rate | Three months | 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
| Measure | Time frame | Description |
|---|---|---|
| Stone free rate in weight's sub group | 3 months | 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 | 3 months | 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 | 3 months | In each arm will be evaluate rate of secondary procedure needed to have the best stone free rate |
| Serious and non serious adverse events | 3 months | In each arm will be evaluate rate of adverse event, type, severity. |
Countries
France
Outcome results
None listed