Condition category
Urological and Genital Diseases
Date applied
10/01/2017
Date assigned
16/02/2017
Last edited
12/09/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Contact information

Type

Scientific

Primary contact

Mr Giorgio Bozzini

ORCID ID

Contact details

via Gerenzano 2
Castellanza
21053
Italy

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 measures

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

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

Sponsor information

Organisation

Humanitas Mater Domini - Castellanza

Sponsor details

via Gerenzano 2
Castellanza
21053
Italy

Sponsor type

Hospital/treatment centre

Website

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

Results - basic reporting

Publication summary

2017 results in: https://www.ncbi.nlm.nih.gov/pubmed/28875295

Publication citations

Additional files

Editorial Notes

12/09/2017: Publication reference added.