RIRS Versus ESWL for the Treatment of Renal Stones

May 7, 2020 updated by: Ettore Dalmasso, University of Turin, Italy

Retrograde Intrarenal Surgery (RIRS) Versus Extracorporeal Shock Waves Lithotripsy (ESWL) for the Treatment of Renal Stones Measuring 6-20 mm: A Prospective Randomized Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Turin, Italy, 10126
        • Urology, University of Turin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: RIRS (retrograde intrarenal surgery)
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.
Procedure: RIRS
Treatment by ureterorenoscopy (RIRS) and laser lithotripsy
Device: Rigid and flexible ureteroscope
Device: Holmium laser
Device: Basket for fragment removal
Procedure: General or spinal anesthesia
Device: X-ray
To focus the stone
Experimental: ESWL (extracorporeal shockwaves lithotripsy)
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.
Device: X-ray
To focus the stone
Procedure: ESWL
Treatment by extracorporeal shock waves lithotripsy
Device: Lithotripter
Drug: Intravenous pain medication
If required by the patient
Device: Ultrasound
To focus the stone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients stone free SFR 4
Time Frame: 1 month from treatment
Patients with residual fragments < 5 mm after treatment
1 month from treatment

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Turin, Italy

Investigators

  • Principal Investigator: Andrea Bosio, Medicine, Urology, University of Turin

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 2, 2015

Primary Completion (Actual)

May 30, 2018

Study Completion (Actual)

June 19, 2019

Study Registration Dates

First Submitted

June 29, 2015

First Submitted That Met QC Criteria

December 31, 2015

First Posted (Estimate)

January 1, 2016

Study Record Updates

Last Update Posted (Actual)

May 11, 2020

Last Update Submitted That Met QC Criteria

May 7, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0016589

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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