Pediatric KIDney Stone (PKIDS) Care Improvement Network
PKIDS
2 other identifiers
observational
1,290
2 countries
31
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2020
Longer than P75 for all trials
31 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 24, 2020
CompletedFirst Posted
Study publicly available on registry
February 26, 2020
CompletedStudy Start
First participant enrolled
April 2, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2024
CompletedFebruary 20, 2024
February 1, 2024
3.6 years
February 24, 2020
February 19, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Stone clearance
Presence or absence of kidney stones will be assessed via post-operative clinically-indicated renal bladder ultrasound.
6 weeks post-op +/- 2 weeks
Secondary Outcomes (3)
Patient-Reported Outcomes
Immediate impact (within 7 days) and delayed impact (up to 90 days) after surgery
Patients' Experiences
Immediate impact (within 7 days) and delayed impact (up to 90 days) after surgery
Patients' Experiences
Up to 90 days after surgery
Study Arms (3)
Ureteroscopy
Percutaneous Nephrolithotomy
Shock Wave Lithotripsy
Interventions
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).
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).
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).
Eligibility Criteria
Pediatric patients in the United States receiving clinical care for kidney stones at a medical facility in the PKIDS Network.
You may qualify if:
- 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
- a. 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.
- b. Individuals for whom native-language questionnaires are not available can also participate in stone clearance assessment and EHR surveillance.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (31)
Children's of Alabama
Birmingham, Alabama, 35233, United States
Children's Hospital Los Angeles
Los Angeles, California, 90027, United States
UCLA Mattel Children's Hospital
Los Angeles, California, 90095, United States
Children's Hospital Colorado
Aurora, Colorado, 80045, United States
Nemours A. I. duPont Hospital for Children
Wilmington, Delaware, 19803, United States
Children's National Health System
Washington D.C., District of Columbia, 20010, United States
University of Florida Health Shands Children's Hospital
Gainesville, Florida, 32608, United States
Nemours Children's Specialty Care
Jacksonville, Florida, 32207, United States
AdventHealth Orlando
Orlando, Florida, 32803, United States
Nemours Children's Hospital
Orlando, Florida, 32827, United States
Children's Hospital of Atlanta
Atlanta, Georgia, 30322, United States
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611, United States
Riley Hospital for Children
Indianapolis, Indiana, 46204, United States
University of Kentucky
Lexington, Kentucky, 40506, United States
Boston Children's Hospital
Boston, Massachusetts, 02115, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
St. Louis Children's Hospital
St Louis, Missouri, 63110, United States
Cohen Children's Medical Center
New York, New York, 11040, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
Nationwide Children's Hospital
Columbus, Ohio, 43205, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Monroe Carell Jr. Children's Hospital at Vanderbilt
Nashville, Tennessee, 37232, United States
Children's Medical Center of Dallas
Dallas, Texas, 75235, United States
Texas Children's Hospital
Houston, Texas, 77030, United States
Primary Children's Hospital
Salt Lake City, Utah, 84113, United States
Children's Hospital of Richmond at VCU
Richmond, Virginia, 23219, United States
Seattle Children's Hospital
Seattle, Washington, 98105, United States
Children's Wisconsin
Milwaukee, Wisconsin, 53226, United States
The Hospital for Sick Children
Toronto, Ontario, M5G 1X8, Canada
Related Publications (2)
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.
PMID: 40773197DERIVEDEllison 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.
PMID: 35383073DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 24, 2020
First Posted
February 26, 2020
Study Start
April 2, 2020
Primary Completion
October 31, 2023
Study Completion
January 31, 2024
Last Updated
February 20, 2024
Record last verified: 2024-02