Pediatric KIDney Stone (PKIDS) Care Improvement Network
NCT ID: NCT04285658
Last Updated: 2024-02-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
1290 participants
OBSERVATIONAL
2020-04-02
2024-01-31
Brief Summary
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Detailed Description
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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
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Ureteroscopy
Ureteroscopy
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 Nephrolithotomy
Percutaneous Nephrolithotomy
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 Lithotripsy
Shock Wave Lithotripsy
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).
Interventions
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Ureteroscopy
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 Nephrolithotomy
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 Lithotripsy
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).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. 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.
Exclusion Criteria
2. Parent/guardians or patients, who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures
8 Years
21 Years
ALL
No
Sponsors
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Patient-Centered Outcomes Research Institute
OTHER
Children's Hospital of Philadelphia
OTHER
Responsible Party
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Locations
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Children's of Alabama
Birmingham, Alabama, United States
Children's Hospital Los Angeles
Los Angeles, California, United States
UCLA Mattel Children's Hospital
Los Angeles, California, United States
Children's Hospital Colorado
Aurora, Colorado, United States
Nemours A. I. duPont Hospital for Children
Wilmington, Delaware, United States
Children's National Health System
Washington D.C., District of Columbia, United States
University of Florida Health Shands Children's Hospital
Gainesville, Florida, United States
Nemours Children's Specialty Care
Jacksonville, Florida, United States
AdventHealth Orlando
Orlando, Florida, United States
Nemours Children's Hospital
Orlando, Florida, United States
Children's Hospital of Atlanta
Atlanta, Georgia, United States
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States
Riley Hospital for Children
Indianapolis, Indiana, United States
University of Kentucky
Lexington, Kentucky, United States
Boston Children's Hospital
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
St. Louis Children's Hospital
St Louis, Missouri, United States
Cohen Children's Medical Center
New York, New York, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Nationwide Children's Hospital
Columbus, Ohio, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Monroe Carell Jr. Children's Hospital at Vanderbilt
Nashville, Tennessee, United States
Children's Medical Center of Dallas
Dallas, Texas, United States
Texas Children's Hospital
Houston, Texas, United States
Primary Children's Hospital
Salt Lake City, Utah, United States
Children's Hospital of Richmond at VCU
Richmond, Virginia, United States
Seattle Children's Hospital
Seattle, Washington, United States
Children's Wisconsin
Milwaukee, Wisconsin, United States
The Hospital for Sick Children
Toronto, Ontario, Canada
Countries
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References
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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.
Ellison 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.
Other Identifiers
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CER-2018C3-14778
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
19-016832
Identifier Type: -
Identifier Source: org_study_id
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