Kidney StoneNCT04317443
A Prospective Observational Comparison of SMP and ESWL for the Treatment of Renal Stones ≥20 mm in Children (IAU-04)
An observational study of Kidney Stone, run by The International Alliance of Urolithiasis.
Trial summary
ESWL and PNL are the two treatment modalities for kidney stones greater than 20 mm in the pediatric population. ESWL is non-invasive, does not require anesthesia and inexpensive, but its success rate may be lower, and require multiple treatment sessions. Read more about this study
- Who is it for?
- Ages Up to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Kidney Stone
- What is being tested?
- Super-mini percutaneous nephrolithotomy (SMP) and Extracorporeal Shock Wave Lithotripsy (ESWL)
- Type of treatment
- Surgery or procedure
- How many people
- 250 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2020to 1 Sep 2021
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Pediatric patients undergoing SWL and SMP
Who may be able to join
- Children ≤14 years old with renal Stones ≥20 mm
- Willing and able to sign informed consent
- Normal renal function
- No stone-related surgical history
- American Society of Anesthesiology (ASA) score 1-2
Who cannot join
- Congenital renal anomalies (horseshoe kidney, ureteropelvic junction obstruction)
- Uncorrected UTI
- Abnormal coagulation function
- Morbid obese children (BMI≥35）
About this study
Official title: A Prospective Observational Comparison of Super-mini Percutaneous Nephrolithotomy (SMP) and Extracorporeal Shock Wave Lithotripsy (ESWL) for the Treatment of Renal Stones ≥20 mm in Children: An IAU Study
ESWL and PNL are the two treatment modalities for kidney stones greater than 20 mm in the pediatric population. ESWL is non-invasive, does not require anesthesia and inexpensive, but its success rate may be lower, and require multiple treatment sessions. On the contrary, PNL has a higher success rate, does not require multiple sessions but is an invasive method. Compared to standard PNL, miniaturized PNL systems have been shown to decrease complications with comparable success rates. SMP is a unique miniaturized PNL system with integrated active irrigation and suction systems. The current literature lacks studies comparing SMP and ESWL prospectively in the pediatric population. In this study, the effectiveness, reliability, and reusability of ESWL and SMP will be compared.
Read the detailed description
To compare the success and complication rates of super-mini-percutaneous nephrolithotomy (SMP) and Extracorporeal Shock Wave Lithotripsy (ESWL) for the treatment of renal stones ≥20 mm in children.An international multicentre, prospective, observational study. Pediatric cases with renal Stones ≥20 mm who undergo ESWL or SMP will be evaluated and compared proespectively. The total number of departments planned to be included in the study is 10 and the number of cases is 180.
- Conditions
- Kidney Stone
- Being tested
- Super-mini percutaneous nephrolithotomy (SMP), Extracorporeal Shock Wave Lithotripsy (ESWL)
- Keywords
- percutaneous nephrolithotomy, pcnl, miniperc, smp, children
- Medical subject headings
- Kidney Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Super-mini percutaneous nephrolithotomy (SMP)Procedure or surgery
SMP will be performed under general anesthesia in prone/supine position. Renal puncture will be performed under ultrasound/fluoroscopy guidance based on the preference of the participating surgeon. Tracts will be dilated to 14 Fr. Stone fragmentation will be performed with holmium laser and fragments will be extracted with the active suction system. For the exit strategy, placement of a nephrostomy tube or JJ stent will be decided by the participating surgeon.
Extracorporeal Shock Wave Lithotripsy (ESWL)Procedure or surgery
ESWL will be performed under sedation/analgesia, shock wave lithotripsy parameters will be determined based on the device and the settings of local center. For patients requiring multiple sessions, maximum 3 (or more) sessions will be allowed. Ureteral stenting prior to ESWL will be performed based on the decision of the participating center.
| Study group | Role | What they receive |
|---|---|---|
| Super-Mini Percutaneous Nephrolithotomy | Patients undergo SMP Receives: Procedure: Super-mini percutaneous nephrolithotomy (SMP) | |
| Extracorporeal Shock Wave Lithotripsy | Patients undergo ESWL Receives: Procedure: Extracorporeal Shock Wave Lithotripsy (ESWL) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stone free rate
Stone clearance on the computed tomography (2mm thickness)
Measured: 3-months
Secondary outcomes (4)
blood loss
Number of participants requiring blood transfusion after the procedure
Measured: Postoperative day 1
auxiliary procedures
Number of patients requiring additional auxiliary procedures such as second look PCNL, SWL, Ureteroscopy
Measured: Postoperative month 3
hospital stay
From date of admission until the date of discharge,length of hospital stay
Measured: Postoperative month 3
complications
Rate of postoperative complications using the Clavien-Dindo system
Measured: Postoperative month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2020
- Study start1 May 2020 (estimated)
- Primary completion1 May 2021 (estimated)
- Study completion1 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney StoneStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- The International Alliance of Urolithiasis
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04317443
- Sponsor's protocol ID
- 2020-01
- Status last verified
- Apr 2020
- First submitted
- 11 Mar 2020
- Last updated
- 30 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Observational Comparison of Super-mini Percutaneous Nephrolithotomy (SMP) and Extracorporeal Shock Wave Lithotripsy (ESWL) for the Treatment of Renal Stones ≥20 mm in Children: An IAU Study
- ClinicalTrials.gov ID
- NCT04317443
- Acronym / sponsor ID
- 2020-01
- Conditions
- Kidney Stone
- Keywords
- percutaneous nephrolithotomy, pcnl, miniperc, smp, children
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- The International Alliance of UrolithiasisResearch network
- Study start
- 1 May 2020 (estimated)
- Primary completion
- 1 May 2021 (estimated)
- Study completion
- 1 Sep 2021 (estimated)
- First posted
- 23 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
ESWL and PNL are the two treatment modalities for kidney stones greater than 20 mm in the pediatric population. ESWL is non-invasive, does not require anesthesia and inexpensive, but its success rate may be lower, and require multiple treatment sessions. On the contrary, PNL has a higher success rate, does not require multiple sessions but is an invasive method. Compared to standard PNL, miniaturized PNL systems have been shown to decrease complications with comparable success rates. SMP is a unique miniaturized PNL system with integrated active irrigation and suction systems. The current literature lacks studies comparing SMP and ESWL prospectively in the pediatric population. In this study, the effectiveness, reliability, and reusability of ESWL and SMP will be compared.
Detailed description
To compare the success and complication rates of super-mini-percutaneous nephrolithotomy (SMP) and Extracorporeal Shock Wave Lithotripsy (ESWL) for the treatment of renal stones ≥20 mm in children.An international multicentre, prospective, observational study. Pediatric cases with renal Stones ≥20 mm who undergo ESWL or SMP will be evaluated and compared proespectively. The total number of departments planned to be included in the study is 10 and the number of cases is 180.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Super-Mini Percutaneous Nephrolithotomy | – | Procedure: Super-mini percutaneous nephrolithotomy (SMP)Patients undergo SMP |
| Extracorporeal Shock Wave Lithotripsy | – | Procedure: Extracorporeal Shock Wave Lithotripsy (ESWL)Patients undergo ESWL |
Who may qualify
- Ages
- Up to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Pediatric patients undergoing SWL and SMP
Key inclusion criteria (5 listed)
- Children ≤14 years old with renal Stones ≥20 mm
- Willing and able to sign informed consent
- Normal renal function
- No stone-related surgical history
- American Society of Anesthesiology (ASA) score 1-2
Key exclusion criteria (4 listed)
- Congenital renal anomalies (horseshoe kidney, ureteropelvic junction obstruction)
- Uncorrected UTI
- Abnormal coagulation function
- Morbid obese children (BMI≥35）
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Super-mini percutaneous nephrolithotomy (SMP)SMP will be performed under general anesthesia in prone/supine position. Renal puncture will be performed under ultrasound/fluoroscopy guidance based on the preference of the participating surgeon. Tracts will be dilated to 14 Fr. Stone fragmentation will be performed with holmium laser and fragments will be extracted with the active suction system. For the exit strategy, placement of a nephrostomy tube or JJ stent will be decided by the participating surgeon. | Procedure or surgery | Super-Mini Percutaneous Nephrolithotomy |
| Extracorporeal Shock Wave Lithotripsy (ESWL)ESWL will be performed under sedation/analgesia, shock wave lithotripsy parameters will be determined based on the device and the settings of local center. For patients requiring multiple sessions, maximum 3 (or more) sessions will be allowed. Ureteral stenting prior to ESWL will be performed based on the decision of the participating center. | Procedure or surgery | Extracorporeal Shock Wave Lithotripsy |
Primary outcome
Stone free rate
Time frame: 3-months
Stone clearance on the computed tomography (2mm thickness)
4 secondary outcomes
blood loss
Time frame: Postoperative day 1
auxiliary procedures
Time frame: Postoperative month 3
hospital stay
Time frame: Postoperative month 3
complications
Time frame: Postoperative month 3
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Stone, run by The International Alliance of Urolithiasis.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stone free rate (time frame: 3-months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2020.