RIRS Versus ESWL for the Treatment of Renal Stones

Renal Stones Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02645058
• Other study ID #: 0016589
• Status: Completed
• Phase: N/A
• Start date: March 2, 2015
• Est. completion date: June 19, 2019

Study information

• Verified date: May 2020
• Source: University of Turin, Italy
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: June 19, 2019
• Est. primary completion date: May 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Kidney Calculi
• Nephrolithiasis
• Renal Stones

Intervention

Procedure:
• RIRS
Treatment by ureterorenoscopy (RIRS) and laser lithotripsy
• ESWL
Treatment by extracorporeal shock waves lithotripsy

Device:
• Rigid and flexible ureteroscope

• Lithotripter

• Holmium laser

• Basket for fragment removal

Procedure:
• General or spinal anesthesia

Drug:
• Intravenous pain medication
If required by the patient

Device:
• X-ray
To focus the stone
• Ultrasound
To focus the stone

Locations

Country	Name	City	State
Italy	Urology, University of Turin	Turin

Sponsors (1)

Lead Sponsor	Collaborator
University of Turin, Italy

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients stone free SFR 4	Patients with residual fragments < 5 mm after treatment	1 month from treatment
Secondary	Number of patients stone free SFR 0	Patients with no residual fragments after treatment	1 month from treatment
Secondary	Number of patients stone free SFR 4	Patients with residual fragments < 5 mm after treatment	6 months after the treatment
Secondary	Number of patients stone free SFR 0	Patients with no residual fragments after treatment	6 months after the treatment
Secondary	Number of patients stone free SFR 4	Patients with residual fragments < 5 mm after treatment	1 year after the treatment
Secondary	Number of patients stone free SFR 0	Patients with no residual fragments after treatment	1 year after the treatment
Secondary	rate of complications	number of complications after treatment	within 1 month form treatment
Secondary	rate of further treatment needed	number of retreatment	within 1 year