Clinical trial NCT02645058: RIRS Versus ESWL for the Treatment of Renal Stones
Official title: Retrograde Intrarenal Surgery (RIRS) Versus Extracorporeal Shock Waves Lithotripsy (ESWL) for the Treatment of Renal Stones Measuring 6-20 mm: A Prospective Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Renal Stones
Keywords: Ureterorenoscopy
extracorporeal shock waves lithotripsy
Lead sponsor: University of Turin, Italy
Sponsor class: OTHER
First posted: 2016-01-01
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the effectiveness of RIRS (retrograde intrarenal surgery) and ESWL (extracorporeal shockwaves lithotripsy) in the treatment of renal stone ranging form 6 to 20 mm size.

Detailed description: European urological guidelines consider RIRS and ESWL the treatments of choice for renal stones \< 20 mm. RIRS is a endoscopic surgery which allows to rich the kidney from the ureter. A flexible ureteroscope is used for these kind of procedure. Through this device a laser fiber (Holmium laser) is used to treat the stones. After that, small fragments can be removed with a basket. In some cases, according to intraoperative findings, a ureteral stent can be push in the kidney to help the drainage of the kidney. ESWL is a procedure which allows to treat the stones by shock waves generated by a specific machine which work in direct contact with the skin of the patients (extracorporeal). Shockwaves pass all the tissues and finally reach the stones. Such energy allows to break the stones in small fragments, that wll be spontaneously passed by the patients. Specific parameters of these treatments are discussed in "Arms and Interventions". Many studies demonstrated high success rate of RIRS and this technique is becoming more and more adopt. One study demonstrated better outcomes of RIRS versus ESWL, but only for renal stones located in the inferior calices and smaller then 10 mm. There are not other studies comparing the two procedures and there are not proofs that RIRS ensures better outcomes for other renal stones (neither for size nor for location).

Eligibility criteria: Inclusion Criteria:

* renal stone measuring 6 to 20 mm
* signing informed consent
* WHO performance status 0-2

Exclusion Criteria:

* Other stone \>5 mm
* concomitant ureteral stones
* BMI \> 35
* severe coagulopathy
* impossibility to sign informed consent
* pregnancy
* age \< 18 years old or \> 85

Primary outcomes:
measure: Number of patients stone free SFR 4
timeFrame: 1 month from treatment
Secondary outcomes:
measure: Number of patients stone free SFR 0
timeFrame: 1 month from treatment
measure: Number of patients stone free SFR 4
timeFrame: 6 months after the treatment
measure: Number of patients stone free SFR 0
timeFrame: 6 months after the treatment
measure: Number of patients stone free SFR 4
timeFrame: 1 year after the treatment
measure: Number of patients stone free SFR 0
timeFrame: 1 year after the treatment
measure: rate of complications
timeFrame: within 1 month form treatment
measure: rate of further treatment needed
timeFrame: within 1 year
Other outcomes:
Locations:
city: Turin
country: Italy
facility: Urology, University of Turin
Study officials:
affiliation: Urology, University of Turin
name: Andrea Bosio, Medicine
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bosio A, Alessandria E, Dalmasso E, Agosti S, Vitiello F, Vercelli E, Bisconti A, Gontero P. Flexible Ureterorenoscopy Versus Shockwave Lithotripsy for Kidney Stones </=2 cm: A Randomized Controlled Trial. Eur Urol Focus. 2022 Nov;8(6):1816-1822. doi: 10.1016/j.euf.2022.04.004. Epub 2022 Apr 22.