search
Back to results

RIRS Versus ESWL for the Treatment of Renal Stones

Primary Purpose

Renal Stones

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
RIRS
ESWL
Rigid and flexible ureteroscope
Lithotripter
Holmium laser
Basket for fragment removal
General or spinal anesthesia
Intravenous pain medication
X-ray
Ultrasound
Sponsored by
University of Turin, Italy
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Renal Stones focused on measuring Ureterorenoscopy, extracorporeal shock waves lithotripsy

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Urology, University of Turin

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

RIRS (retrograde intrarenal surgery)

ESWL (extracorporeal shockwaves lithotripsy)

Arm Description

In the first arm (RIRS) the patients will be treated by a standard retrograde ureterorenoscopy and Holmium laser lithotripsy. Preoperative exams will be abdomen ultrasound and Xray (CT in case of stones > 15 mm), urine analysis and culture (according to all the more recent guidelines). Surgeries will be performed under general or spinal anesthesia, according to anesthesiologist evaluation. According with standard technique, ureteroscopy will be performed using both rigid and flexible ureteroscope. Lithotripsy will be performed by Holmium laser. Major stone fragments will be removed at the end of the procedure. Finally a double J ureteral stent will be push in specific cases depending on intraoperative findings (length of the procedure, macroscopic view of the ureter, residual stones etc.). RIRS will be an outpatients procedure with an hospital stay <23 hours. Some patients may require a longer hospital stay due to specific pre-operative diseases or intra/post-operative events.

In the second arm (ESWL) the patients will be treated by a standard extracorporeal shock waves lithotripsy (ESWL). Preoperative exams will be the same as first arm. No general or spinal anaesthesia will be used, but just intravenous medications if required. Ultrasound and/or X-Ray will be used to locate the stone. Power and number of shock waves will consist in 20-24 KV and 3000-3500 sw respectively, according to individual tolerance. ESWL will be an outpatients procedure with an hospital stay <23 hours. Some patients may require a longer hospital stay due to specific pre-operative diseases or intra/post-operative events.

Outcomes

Primary Outcome Measures

Number of patients stone free SFR 4
Patients with residual fragments < 5 mm after treatment

Secondary Outcome Measures

Number of patients stone free SFR 0
Patients with no residual fragments after treatment
Number of patients stone free SFR 4
Patients with residual fragments < 5 mm after treatment
Number of patients stone free SFR 0
Patients with no residual fragments after treatment
Number of patients stone free SFR 4
Patients with residual fragments < 5 mm after treatment
Number of patients stone free SFR 0
Patients with no residual fragments after treatment
rate of complications
number of complications after treatment
rate of further treatment needed
number of retreatment

Full Information

First Posted
June 29, 2015
Last Updated
May 7, 2020
Sponsor
University of Turin, Italy
search

1. Study Identification

Unique Protocol Identification Number
NCT02645058
Brief Title
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

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
March 2, 2015 (Actual)
Primary Completion Date
May 30, 2018 (Actual)
Study Completion Date
June 19, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Turin, Italy

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Stones
Keywords
Ureterorenoscopy, extracorporeal shock waves lithotripsy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
RIRS (retrograde intrarenal surgery)
Arm Type
Experimental
Arm Description
In the first arm (RIRS) the patients will be treated by a standard retrograde ureterorenoscopy and Holmium laser lithotripsy. Preoperative exams will be abdomen ultrasound and Xray (CT in case of stones > 15 mm), urine analysis and culture (according to all the more recent guidelines). Surgeries will be performed under general or spinal anesthesia, according to anesthesiologist evaluation. According with standard technique, ureteroscopy will be performed using both rigid and flexible ureteroscope. Lithotripsy will be performed by Holmium laser. Major stone fragments will be removed at the end of the procedure. Finally a double J ureteral stent will be push in specific cases depending on intraoperative findings (length of the procedure, macroscopic view of the ureter, residual stones etc.). RIRS will be an outpatients procedure with an hospital stay <23 hours. Some patients may require a longer hospital stay due to specific pre-operative diseases or intra/post-operative events.
Arm Title
ESWL (extracorporeal shockwaves lithotripsy)
Arm Type
Experimental
Arm Description
In the second arm (ESWL) the patients will be treated by a standard extracorporeal shock waves lithotripsy (ESWL). Preoperative exams will be the same as first arm. No general or spinal anaesthesia will be used, but just intravenous medications if required. Ultrasound and/or X-Ray will be used to locate the stone. Power and number of shock waves will consist in 20-24 KV and 3000-3500 sw respectively, according to individual tolerance. ESWL will be an outpatients procedure with an hospital stay <23 hours. Some patients may require a longer hospital stay due to specific pre-operative diseases or intra/post-operative events.
Intervention Type
Procedure
Intervention Name(s)
RIRS
Intervention Description
Treatment by ureterorenoscopy (RIRS) and laser lithotripsy
Intervention Type
Procedure
Intervention Name(s)
ESWL
Intervention Description
Treatment by extracorporeal shock waves lithotripsy
Intervention Type
Device
Intervention Name(s)
Rigid and flexible ureteroscope
Intervention Type
Device
Intervention Name(s)
Lithotripter
Intervention Type
Device
Intervention Name(s)
Holmium laser
Intervention Type
Device
Intervention Name(s)
Basket for fragment removal
Intervention Type
Procedure
Intervention Name(s)
General or spinal anesthesia
Intervention Type
Drug
Intervention Name(s)
Intravenous pain medication
Intervention Description
If required by the patient
Intervention Type
Device
Intervention Name(s)
X-ray
Intervention Description
To focus the stone
Intervention Type
Device
Intervention Name(s)
Ultrasound
Intervention Description
To focus the stone
Primary Outcome Measure Information:
Title
Number of patients stone free SFR 4
Description
Patients with residual fragments < 5 mm after treatment
Time Frame
1 month from treatment
Secondary Outcome Measure Information:
Title
Number of patients stone free SFR 0
Description
Patients with no residual fragments after treatment
Time Frame
1 month from treatment
Title
Number of patients stone free SFR 4
Description
Patients with residual fragments < 5 mm after treatment
Time Frame
6 months after the treatment
Title
Number of patients stone free SFR 0
Description
Patients with no residual fragments after treatment
Time Frame
6 months after the treatment
Title
Number of patients stone free SFR 4
Description
Patients with residual fragments < 5 mm after treatment
Time Frame
1 year after the treatment
Title
Number of patients stone free SFR 0
Description
Patients with no residual fragments after treatment
Time Frame
1 year after the treatment
Title
rate of complications
Description
number of complications after treatment
Time Frame
within 1 month form treatment
Title
rate of further treatment needed
Description
number of retreatment
Time Frame
within 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrea Bosio, Medicine
Organizational Affiliation
Urology, University of Turin
Official's Role
Principal Investigator
Facility Information:
Facility Name
Urology, University of Turin
City
Turin
ZIP/Postal Code
10126
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
35466071
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.
Results Reference
derived

Learn more about this trial

RIRS Versus ESWL for the Treatment of Renal Stones

We'll reach out to this number within 24 hrs