Kidney StonePKIDSNCT04285658
Pediatric KIDney Stone (PKIDS) Care Improvement Network
An observational study of Kidney Stone and Nephrolithiasis, run by Children's Hospital of Philadelphia at 31 sites in 2 countries.
Trial summary
The goals of this study are to improve the ability of pediatric patients and their caregivers to select surgical treatment options for kidney stones and to enable urologists to use techniques that result in the best outcomes for these surgeries. Read more about this study
- Who is it for?
- Ages 8 to 21 years
- Conditions the study is for
- Kidney Stone, Nephrolithiasis
- What is being tested?
- Ureteroscopy, Percutaneous Nephrolithotomy and Shock Wave Lithotripsy
- Type of treatment
- Surgery or procedure
- How many people
- 1,290 participants
- Where
- 31 sitesin 2 countries
- Study dates
- 2 Apr 2020to 31 Jan 2024
- 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 8 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Pediatric patients in the United States receiving clinical care for kidney stones at a medical facility in the PKIDS Network.
Who may be able to join
- Males or females, 8-21 years of age, undergoing planned URS, SWL, or PCNL for the removal of at least one kidney and/or ureteral stone.
- Parental/guardian or participant (if ≥ 18 years old) permission (informed consent), and if appropriate, child assent
- 2a. Individuals who are not able to provide consent/assent (whether ≥18 or < 18 years) and/or not willing or able to complete questionnaires are eligible for participation for the stone clearance assessment and Electronic Health Record (EHR) surveillance if the legal guardian consents for study participation.
- 2b. Individuals for whom native-language questionnaires are not available can also participate in stone clearance assessment and EHR surveillance.
Who cannot join
- Patients for whom conducting informed consent and baseline study procedures would confer additional risk (e.g. obstructing ureteral stone with fever requiring emergency surgery) and delay necessary immediate clinical care.
- Parent/guardians or patients, who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures
Trial locations and contacts
31 sites in 2 countries.
31 sites in 2 countries
United States30 sites
University of Michigan
Ann Arbor, Michigan, 48109
Children's Hospital of Atlanta
Atlanta, Georgia, 30322
Children's Hospital Colorado
Aurora, Colorado, 80045
Children's of Alabama
Birmingham, Alabama, 35233
Boston Children's Hospital
Boston, Massachusetts, 02115
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Nationwide Children's Hospital
Columbus, Ohio, 43205
Children's Medical Center of Dallas
Dallas, Texas, 75235
University of Florida Health Shands Children's Hospital
Gainesville, Florida, 32608
Texas Children's Hospital
Houston, Texas, 77030
Riley Hospital for Children
Indianapolis, Indiana, 46204
Nemours Children's Specialty Care
Jacksonville, Florida, 32207
University of Kentucky
Lexington, Kentucky, 40506
Children's Hospital Los Angeles
Los Angeles, California, 90027
UCLA Mattel Children's Hospital
Los Angeles, California, 90095
Children's Wisconsin
Milwaukee, Wisconsin, 53226
Monroe Carell Jr. Children's Hospital at Vanderbilt
Nashville, Tennessee, 37232
Cohen Children's Medical Center
New York, New York, 11040
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
AdventHealth Orlando
Orlando, Florida, 32803
Nemours Children's Hospital
Orlando, Florida, 32827
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Children's Hospital of Richmond at VCU
Richmond, Virginia, 23219
Primary Children's Hospital
Salt Lake City, Utah, 84113
Seattle Children's Hospital
Seattle, Washington, 98105
St. Louis Children's Hospital
St Louis, Missouri, 63110
Children's National Health System
Washington D.C., District of Columbia, 20010
Nemours A. I. duPont Hospital for Children
Wilmington, Delaware, 19803
About this study
The goals of this study are to improve the ability of pediatric patients and their caregivers to select surgical treatment options for kidney stones and to enable urologists to use techniques that result in the best outcomes for these surgeries.
Read the detailed description
The rapid increase in the incidence of kidney stones among youth has resulted in a large population of patients who require surgery to removes stones but for whom little evidence exists to guide clinical care. Proper selection of surgical treatment options, which is directed by patient-specific factors and individual treatment goals, is the greatest determinant of successful outcomes.
This is a prospective cohort study. Investigators seek to compare stone clearance, re-treatment, and unplanned healthcare encounters for ureteroscopy, shockwave lithotripsy, and percutaneous nephrolithotomy.
Additionally, Investigators also seek to compare patients' experiences after ureteroscopy, shockwave lithotripsy, and percutaneous nephrolithotomy.
Setting/Participants:
This study will be conducted by the Pediatric KIDney Stone (PKIDS) Care Improvement Network, which includes 23 pediatric healthcare systems (25 sites) in the United States.
Patient participants include patients aged 8 to 21 years who undergo a surgical intervention for kidney stones as part of their clinical care. The surgical interventions include ureteroscopy, shockwave lithotripsy, and percutaneous nephrolithotomy, all of which would be performed as part of routine clinical care.
Study Interventions and Measures:
Stone clearance will be assessed with ultrasound (obtained as part of clinical care) 6 weeks after surgery, which is the standard of care at all PKIDS sites. Re-treatment and unplanned healthcare encounters will be assessed within the first 3 months after surgery. Patients' experiences will be measured through questionnaires administered pre-operatively and within 3 months after surgery.
- Conditions
- Kidney Stone, Nephrolithiasis
- Being tested
- Ureteroscopy, Percutaneous Nephrolithotomy, Shock Wave Lithotripsy
- Keywords
- kidney, kidney stone, nephrolithiasis, Comparative Effectiveness, Patient Reported Outcomes
- Medical subject headings
- Kidney Calculi, Nephrolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UreteroscopyProcedure or surgery
Also called URS
An outpatient endoscopic surgery that accesses the ureters and kidneys per the urethra to fragment and remove the stones. Many patients who undergo ureteroscopy (URS), Shockwave lithotripsy (SWL), or percutaneous nephrolithotomy (PCNL) also have temporary tubes placed after the surgery to facilitate drainage, either internally (a stent) or externally (a nephrostomy tube).
Percutaneous NephrolithotomyProcedure or surgery
Also called PCNL
A minimally invasive surgery in which a ~1cm flank incision is made, and a scope is passed through a tubular sheath into the kidney to fragment and remove the stone. There is typically a 1- to 2-day hospital stay. Many patients who undergo URS, SWL, or PCNL also have temporary tubes placed after the surgery to facilitate drainage, either internally (a stent) or externally (a nephrostomy tube).
Shock Wave LithotripsyProcedure or surgery
Also called SWL
A non-invasive outpatient procedure that targets stones in the kidney or ureter with x-ray or ultrasound and uses shockwaves generated outside the body to fragment them; the fragments pass down the ureter and the patient expels them in the urine. Many patients who undergo URS, SWL, or PCNL also have temporary tubes placed after the surgery to facilitate drainage, either internally (a stent) or externally (a nephrostomy tube).
| Study group | Role | What they receive |
|---|---|---|
| Ureteroscopy | Not described Receives: Procedure: Ureteroscopy | |
| Percutaneous Nephrolithotomy | Not described Receives: Procedure: Percutaneous Nephrolithotomy | |
| Shock Wave Lithotripsy | Not described Receives: Procedure: Shock Wave Lithotripsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stone clearance
Presence or absence of kidney stones will be assessed via post-operative clinically-indicated renal bladder ultrasound.
Measured: 6 weeks post-op +/- 2 weeks
Secondary outcomes (3)
Patient-Reported Outcomes
Patients' experiences before and after URS, SWL, and PCNL will be measured. Investigators will assess the immediate and delayed impact of surgery on patient-reported outcomes (PROs) selected by PKIDS patient partners. The patient reported outcomes (PROs) include the Patient-Reported Outcomes Measurement Information System (PROMIS), other questionnaires commonly used in studying the impact of kidney stone disease on health states, and urinary tract symptoms.
Measured: Immediate impact (within 7 days) and delayed impact (up to 90 days) after surgery
Patients' Experiences
Investigators will examine Heterogeneity of Treatment Effect (HTE) by age and sex and identify modifiable surgical techniques that impact patient experiences for each surgery.
Measured: Immediate impact (within 7 days) and delayed impact (up to 90 days) after surgery
Patients' Experiences
Investigators will also determine unplanned hospitalizations, emergency department (ED) visits, and repeat surgeries for the 3 months following each procedure to examine impact on patients' experiences.
Measured: Up to 90 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2020
- Study start2 Apr 2020
- Primary completion31 Oct 2023
- Study completion31 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Kidney StoneStudies of the same condition, open and under way.
- More trials run by Children's Hospital of PhiladelphiaThe sponsor's other registered studies.
- 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
- 1,290 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04285658
- Sponsor's protocol ID
- 19-016832
- Other IDs
- CER-2018C3-14778
- Acronym
- PKIDS
- Status last verified
- Feb 2024
- First submitted
- 24 Feb 2020
- Last updated
- 20 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Tasian GE, Chu DI, Nelson CP, DeFoor WR, Ziemba JB, Huang J, Luan X, Kurtz M, Ching CB, Dangle P, Schaeffer AJ, Sturm R, Wu W, Bayne C, Fernandez N, Chua ME, DeMarco R, Ellsworth P, Augelli B, Bi-Karchin J, McCune RD, Vatsky S, Back S, Wang Z, Beck H, Kurth A, Kurth L, Pleskoff A, Forrest CB, Ellison JS; PKIDS Care Improvement Network; Rove K, Sparks S, Nelson E, Schlomer B, Krill A, Tong CMC, Taylor A, Ramachandra P, Stec A, Casale P, Coplen D, Janzen N, Bagley K, Denburg MR, Dickinson K, Laberee R, Lorenzo M, Selman-Fermin A, Dos Santos J, Grant C, Kraft K, Meenakshi-Sundaram B. Ureteroscopy vs Shockwave Lithotripsy to Remove Kidney Stones in Children and Adolescents: A Nonrandomized Clinical Trial. JAMA Netw Open. 2025 Aug 1;8(8):e2525789. doi: 10.1001/jamanetworkopen.2025.25789.
PubMed 40773197Ellison JS, Lorenzo M, Beck H, Beck R, Chu DI, Forrest C, Huang J, Kratchman A, Kurth A, Kurth L, Kurtz M, Lendvay T, Sturm R, Tasian G; Pediatric KIDney Stone Care Improvement Network. Comparative effectiveness of paediatric kidney stone surgery (the PKIDS trial): study protocol for a patient-centred pragmatic clinical trial. BMJ Open. 2022 Apr 5;12(4):e056789. doi: 10.1136/bmjopen-2021-056789.
PubMed 35383073
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pediatric KIDney Stone (PKIDS) Care Improvement Network
- ClinicalTrials.gov ID
- NCT04285658
- Acronym / sponsor ID
- PKIDS / 19-016832
- Conditions
- Kidney Stone, Nephrolithiasis
- Keywords
- kidney, kidney stone, nephrolithiasis, Comparative Effectiveness, Patient Reported Outcomes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,290 participants (actual)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Study start
- 2 Apr 2020 (actual)
- Primary completion
- 31 Oct 2023 (actual)
- Study completion
- 31 Jan 2024 (actual)
- First posted
- 26 Feb 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.
The goals of this study are to improve the ability of pediatric patients and their caregivers to select surgical treatment options for kidney stones and to enable urologists to use techniques that result in the best outcomes for these surgeries.
Detailed description
The rapid increase in the incidence of kidney stones among youth has resulted in a large population of patients who require surgery to removes stones but for whom little evidence exists to guide clinical care. Proper selection of surgical treatment options, which is directed by patient-specific factors and individual treatment goals, is the greatest determinant of successful outcomes.
This is a prospective cohort study. Investigators seek to compare stone clearance, re-treatment, and unplanned healthcare encounters for ureteroscopy, shockwave lithotripsy, and percutaneous nephrolithotomy.
Additionally, Investigators also seek to compare patients' experiences after ureteroscopy, shockwave lithotripsy, and percutaneous nephrolithotomy.
Setting/Participants:
This study will be conducted by the Pediatric KIDney Stone (PKIDS) Care Improvement Network, which includes 23 pediatric healthcare systems (25 sites) in the United States.
Patient participants include patients aged 8 to 21 years who undergo a surgical intervention for kidney stones as part of their clinical care. The surgical interventions include ureteroscopy, shockwave lithotripsy, and percutaneous nephrolithotomy, all of which would be performed as part of routine clinical care.
Study Interventions and Measures:
Stone clearance will be assessed with ultrasound (obtained as part of clinical care) 6 weeks after surgery, which is the standard of care at all PKIDS sites. Re-treatment and unplanned healthcare encounters will be assessed within the first 3 months after surgery. Patients' experiences will be measured through questionnaires administered pre-operatively and within 3 months after surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ureteroscopy | – | Procedure: Ureteroscopy |
| Percutaneous Nephrolithotomy | – | Procedure: Percutaneous Nephrolithotomy |
| Shock Wave Lithotripsy | – | Procedure: Shock Wave Lithotripsy |
Who may qualify
- Ages
- 8 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Pediatric patients in the United States receiving clinical care for kidney stones at a medical facility in the PKIDS Network.
Key inclusion criteria (4 listed)
- Males or females, 8-21 years of age, undergoing planned URS, SWL, or PCNL for the removal of at least one kidney and/or ureteral stone.
- Parental/guardian or participant (if ≥ 18 years old) permission (informed consent), and if appropriate, child assent
- 2a. Individuals who are not able to provide consent/assent (whether ≥18 or < 18 years) and/or not willing or able to complete questionnaires are eligible for participation for the stone clearance assessment and Electronic Health Record (EHR) surveillance if the legal guardian consents for study participation.
- 2b. Individuals for whom native-language questionnaires are not available can also participate in stone clearance assessment and EHR surveillance.
Key exclusion criteria (2 listed)
- Patients for whom conducting informed consent and baseline study procedures would confer additional risk (e.g. obstructing ureteral stone with fever requiring emergency surgery) and delay necessary immediate clinical care.
- Parent/guardians or patients, who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures
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 |
|---|---|---|
| UreteroscopyAlso: URSAn outpatient endoscopic surgery that accesses the ureters and kidneys per the urethra to fragment and remove the stones. Many patients who undergo ureteroscopy (URS), Shockwave lithotripsy (SWL), or percutaneous nephrolithotomy (PCNL) also have temporary tubes placed after the surgery to facilitate drainage, either internally (a stent) or externally (a nephrostomy tube). | Procedure or surgery | Ureteroscopy |
| Percutaneous NephrolithotomyAlso: PCNLA minimally invasive surgery in which a ~1cm flank incision is made, and a scope is passed through a tubular sheath into the kidney to fragment and remove the stone. There is typically a 1- to 2-day hospital stay. Many patients who undergo URS, SWL, or PCNL also have temporary tubes placed after the surgery to facilitate drainage, either internally (a stent) or externally (a nephrostomy tube). | Procedure or surgery | Percutaneous Nephrolithotomy |
| Shock Wave LithotripsyAlso: SWLA non-invasive outpatient procedure that targets stones in the kidney or ureter with x-ray or ultrasound and uses shockwaves generated outside the body to fragment them; the fragments pass down the ureter and the patient expels them in the urine. Many patients who undergo URS, SWL, or PCNL also have temporary tubes placed after the surgery to facilitate drainage, either internally (a stent) or externally (a nephrostomy tube). | Procedure or surgery | Shock Wave Lithotripsy |
Primary outcome
Stone clearance
Time frame: 6 weeks post-op +/- 2 weeks
Presence or absence of kidney stones will be assessed via post-operative clinically-indicated renal bladder ultrasound.
3 secondary outcomes
Patient-Reported Outcomes
Time frame: Immediate impact (within 7 days) and delayed impact (up to 90 days) after surgery
Patients' Experiences
Time frame: Immediate impact (within 7 days) and delayed impact (up to 90 days) after surgery
Patients' Experiences
Time frame: Up to 90 days after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
- Derived from this study: PubMed 40773197Tasian GE, Chu DI, Nelson CP, DeFoor WR, Ziemba JB, Huang J, Luan X, Kurtz M, Ching CB, Dangle P, Schaeffer AJ, Sturm R, Wu W, Bayne C, Fernandez N, Chua ME, DeMarco R, Ellsworth P, Augelli B, Bi-Karchin J, McCune RD, Vatsky S, Back S, Wang Z, Beck H, Kurth A, Kurth L, Pleskoff A, Forrest CB, Ellison JS; PKIDS Care Improvement Network; Rove K, Sparks S, Nelson E, Schlomer B, Krill A, Tong CMC, Taylor A, Ramachandra P, Stec A, Casale P, Coplen D, Janzen N, Bagley K, Denburg MR, Dickinson K, Laberee R, Lorenzo M, Selman-Fermin A, Dos Santos J, Grant C, Kraft K, Meenakshi-Sundaram B. Ureteroscopy vs Shockwave Lithotripsy to Remove Kidney Stones in Children and Adolescents: A Nonrandomized Clinical Trial. JAMA Netw Open. 2025 Aug 1;8(8):e2525789. doi: 10.1001/jamanetworkopen.2025.25789.
- Derived from this study: PubMed 35383073Ellison JS, Lorenzo M, Beck H, Beck R, Chu DI, Forrest C, Huang J, Kratchman A, Kurth A, Kurth L, Kurtz M, Lendvay T, Sturm R, Tasian G; Pediatric KIDney Stone Care Improvement Network. Comparative effectiveness of paediatric kidney stone surgery (the PKIDS trial): study protocol for a patient-centred pragmatic clinical trial. BMJ Open. 2022 Apr 5;12(4):e056789. doi: 10.1136/bmjopen-2021-056789.
- Individual participant dataSharing planned: Undecided
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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.
31 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Stone and Nephrolithiasis, run by Children's Hospital of Philadelphia at 31 sites in 2 countries.
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 4 inclusion and 2 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: finished, as of the sponsor's last update on 20 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 clearance (time frame: 6 weeks post-op +/- 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04285658, which also lists 2 linked publications.
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 20 Feb 2024.