Plain English Summary
Background and study aims
Kidney stones are hard stones that form in the kidneys. If a stone blocks part of the urinary system, such as the ureter (the tube connecting the kidney to the bladder) or the urethra (the tube urine passes through on its way out of the body), this can cause severe pain. The aim of this study is to compare three treatments for kidney stones: Retrograde IntraRenal Surgery (RIRS), Shock Wave Lithotripsy (SWL) and Percutaneous Lithotripsy (PCNL). RIRS involves passing a long, thin telescope (ureteroscope) through the urethra, into the bladder and up into the ureter, where the stone is broken up using a laser. SWL involves using ultrasound shock waves to break the stone into smaller pieces. PCNL involves passing a thin telescopic instrument (nephroscope) through a small incision (cut) into the kidney, and the stone is broken up using a laser.
Who can participate?
Patients aged between 18 and 75 with a single lower pole kidney stone with a diameter of 1 to 2 cm
What does the study involve?
Participants are randomly allocated to undergo either SWL, RIRS or PCNL, as described above. Participants undergo an x-ray or ultrasound scan after 10 days and a CT scan after 3 months to find out whether they are now stone free. Any complications of the procedures are recorded during hospitalization and at 3 months follow-up.
What are the possible benefits and risks of participating?
Participants benefit from treatment with brand new devices.
Where is the study run from?
1. Humanitas Mater Domini (Italy)
2. San Paolo Hospital (Italy)
3. Federico II Napoli (Italy)
4. Seconda Univ. Napoli (Italy)
5. Graz General Hospital (Austria)
6. Lomonosov Univ Moscow (Russia)
7. King's College Hospital (UK)
When is the study starting and how long is it expected to run for?
January 2010 to December 2014
Who is funding the study?
European Association of Urology (Netherlands)
Who is the main contact?
Giorgio Bozzini
Trial website
Additional identifiers
EudraCT number
2009-001328-14
ClinicalTrials.gov number
Protocol/serial number
77/gb/2009
Study information
Scientific title
A prospective randomized comparison among shock wave lithotripsy, percutaneous lithotripsy and retrograde intrarenal surgery for lower calyceal stones less than 2 cm: a multicenter experience
Acronym
Study hypothesis
To prospectively evaluate the efficacy and safety of Retrograde IntraRenal Surgery (RIRS), Shock Wave Lithotripsy (SWL) and Percutaneous Lithotripsy (PCNL) for lower calyceal stones sized 1-2 cm.
Ethics approval
ASL Milano 2, 12/03/2009, ref: 2009/2388/DU
Study design
Multicenter randomized unblinded clinical trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
Renal lower calyceal stones
Intervention
Patients will be randomized into three groups:
Group A: SWL
Group B: RIRS
Group C: PCNL
The randomization allocation sequence will be produced with the online free Random Allocation Software (M. Saghaei, MD). The principal investigator for each center will enroll and assign participants to groups. The randomization will be stratified by center. Each center will use their own equipment to perform treatments, but the procedures will be standardized and were supervised by an experienced surgeon in the field of stone management.
SWL will be performed with ultrasound or x-ray guided targeting of the stone with a frequency of 100 impulses/min and a maximum of 2500 shock waves (SW) per session. Patients will be observed for at least two hours after the SWL and then discharged as an outpatient procedure.
RIRS will be performed with a flexible ureteroscope and a 30 W Holmium YAG Laser device. Before the sheath insertion, an ureteric dilatation will be performed when required. Bigger fragments will be removed with a stone retrieval basket. After the procedure a double J stent will be inserted in all patients and its removal will be planned after 4 weeks if the patient will be stone free.
PCNL will be performed with a rigid nephroscope 20.8 to 24 Fr. and a 30 W Holmium YAG Laser device. PCNL will be performed with the patient either in prone or modified supine position according to the operator’s preference. The kidney puncture will be performed under fluoroscopic and/or US guidance. Calyx will be cleaned removing bigger fragments with a stone retrieval basket. Each patient will have a nephrostomy tube placement after the procedure removed after two days if urine is clear.
A stone analysis will be performed in all cases, when fragments available. Patients affected by uric acid stones will be treated with oral chemolysis in order to reach the stone free status.
Patients will be evaluated with kidney-ureter-bladder (KUB) radiography after 10 days (ultrasonography for uric acid stones) and a CT scan after 3 months, unless residual fragments will be present after the first treatment session.
Intervention type
Procedure/Surgery
Phase
Drug names
Primary outcome measure
Stone-free rate (SFR), defined as a negative CT scan or an asymptomatic patient with stone fragments less than 3 mm and a negative urine culture, measured at 3 months
Secondary outcome measures
Peri- and post-operative complications of procedures, classified using the validated Dindo-modified Clavien System, during the hospitalization and until 3 months
Overall trial start date
01/01/2010
Overall trial end date
31/12/2014
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Consecutive patients with a single LP stone with a diameter of 1 to 2 cm as measured at CT scan, that received the indication of active removal according to EAU Guidelines
2. Age between 18 and 75 years
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
176 per arm
Participant exclusion criteria
1. Presence of coagulation disorders
2. Age under 18 or over 75 years
3. Presence of acute infection (fever more than 38° C or total leucocyte count more than 15000/dl)
4. Presence of solitary kidney
5. Coexisting ureteric disease (tumour or stricture)
6. Pregnancy
7. Presence of cardiovascular or pulmonary comorbidities
8. Multiple stones
9. Steep infundibolar-pelvic angle (< 30°)
10. Longer calyx more than 10 mm
11. Narrow infundibulum (less than 5 mm) as demonstrated by contrast enhanced CT
12. Patients who refuse to give consent to the study
Recruitment start date
01/01/2010
Recruitment end date
30/06/2014
Locations
Countries of recruitment
Austria, Italy, Russian Federation, United Kingdom
Trial participating centre
Humanitas Mater Domini
Castellanza
21053
Italy
Trial participating centre
San Paolo Hospital
Milan
20100
Italy
Trial participating centre
Federico II Napoli
Naples
80121
Italy
Trial participating centre
Seconda Univ. Napoli
Naples
80121
Italy
Trial participating centre
Graz General Hospital
Graz
8020
Austria
Trial participating centre
Lomonosov Univ Moscow
Moscow
101
Russian Federation
Trial participating centre
King's College Hospital
London
SE5 9RS
United Kingdom
Funders
Funder type
Research organisation
Funder name
European Association of Urology
Alternative name(s)
EAU
Funding Body Type
private sector organisation
Funding Body Subtype
professional associations and societies
Location
Netherlands
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer review journal after one year of the end of the study
IPD sharing plan
The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication
Intention to publish date
01/06/2015
Participant level data
Other
Basic results (scientific)
Publication list
2017 results in: https://www.ncbi.nlm.nih.gov/pubmed/28875295