- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04285658
Pediatric KIDney Stone (PKIDS) Care Improvement Network (PKIDS)
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Contact
- Name: Director of PKIDS Operations
- Phone Number: 215-516-9697
- Email: pkids@chop.edu
Study Locations
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Ontario
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Toronto, Ontario, Canada, M5G 1X8
- The Hospital for Sick Children
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Alabama
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Birmingham, Alabama, United States, 35233
- Children's of Alabama
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California
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Los Angeles, California, United States, 90027
- Children's Hospital Los Angeles
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Los Angeles, California, United States, 90095
- UCLA Mattel Children's Hospital
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Colorado
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Aurora, Colorado, United States, 80045
- Children's Hospital Colorado
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Delaware
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Wilmington, Delaware, United States, 19803
- Nemours A. I. duPont Hospital for Children
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District of Columbia
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Washington, District of Columbia, United States, 20010
- Children's National Health System
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Florida
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Gainesville, Florida, United States, 32608
- University of Florida Health Shands Children's Hospital
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Jacksonville, Florida, United States, 32207
- Nemours Children's Specialty Care
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Orlando, Florida, United States, 32827
- Nemours Children's Hospital
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Orlando, Florida, United States, 32803
- AdventHealth Orlando
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Georgia
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Atlanta, Georgia, United States, 30322
- Children's Hospital of Atlanta
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Illinois
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Chicago, Illinois, United States, 60611
- Ann & Robert H. Lurie Children's Hospital of Chicago
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Indiana
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Indianapolis, Indiana, United States, 46204
- Riley Hospital for Children
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Kentucky
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Lexington, Kentucky, United States, 40506
- University of Kentucky
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Massachusetts
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Boston, Massachusetts, United States, 02115
- Boston Children's Hospital
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Michigan
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Ann Arbor, Michigan, United States, 48109
- University of Michigan
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Missouri
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Saint Louis, Missouri, United States, 63110
- St. Louis Children's Hospital
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New York
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New York, New York, United States, 11040
- Cohen Children's Medical Center
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Ohio
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Cincinnati, Ohio, United States, 45229
- Cincinnati Children's Hospital Medical Center
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Columbus, Ohio, United States, 43205
- Nationwide Children's Hospital
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Oklahoma
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Oklahoma City, Oklahoma, United States, 73104
- University of Oklahoma Health Sciences Center
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- Children's Hospital of Philadelphia
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Philadelphia, Pennsylvania, United States, 19104
- University of Pennsylvania
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Tennessee
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Nashville, Tennessee, United States, 37232
- Monroe Carell Jr. Children's Hospital at Vanderbilt
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Texas
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Dallas, Texas, United States, 75235
- Children's Medical Center of Dallas
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Houston, Texas, United States, 77030
- Texas Children's Hospital
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Utah
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Salt Lake City, Utah, United States, 84113
- Primary Children's Hospital
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Virginia
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Richmond, Virginia, United States, 23219
- Children's Hospital of Richmond at VCU
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Washington
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Seattle, Washington, United States, 98105
- Seattle Children's Hospital
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Wisconsin
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Milwaukee, Wisconsin, United States, 53226
- Children's Wisconsin
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Ureteroscopy
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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).
Other Names:
|
Percutaneous Nephrolithotomy
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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).
Other Names:
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Shock Wave Lithotripsy
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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 Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Stone clearance
Time Frame: 6 weeks post-op +/- 2 weeks
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Presence or absence of kidney stones will be assessed via post-operative clinically-indicated renal bladder ultrasound.
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6 weeks post-op +/- 2 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient-Reported Outcomes
Time Frame: Immediate impact (within 7 days) and delayed impact (up to 90 days) after surgery
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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.
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Immediate impact (within 7 days) and delayed impact (up to 90 days) after surgery
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Patients' Experiences
Time Frame: Immediate impact (within 7 days) and delayed impact (up to 90 days) after surgery
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Investigators will examine Heterogeneity of Treatment Effect (HTE) by age and sex and identify modifiable surgical techniques that impact patient experiences for each surgery.
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Immediate impact (within 7 days) and delayed impact (up to 90 days) after surgery
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Patients' Experiences
Time Frame: Up to 90 days after surgery
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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.
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Up to 90 days after surgery
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Collaborators and Investigators
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 19-016832
- CER-2018C3-14778 (Other Grant/Funding Number: Patient-Centered Outcomes Research Institute)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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