Pediatric KIDney Stone (PKIDS) Care Improvement Network

Sponsor

Children's Hospital of Philadelphia (Other)

Overall Status

Recruiting

CT.gov ID

NCT04285658

Collaborator

Patient-Centered Outcomes Research Institute (Other)

1,290

Enrollment

Locations

Anticipated Duration (Months)

41.6

Patients Per Site

0.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Kidney Stone Nephrolithiasis	Procedure: Ureteroscopy Procedure: Percutaneous Nephrolithotomy Procedure: Shock Wave Lithotripsy

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

Study Type:

Observational

Anticipated Enrollment :

1290 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Pediatric KIDney Stone (PKIDS) Care Improvement Network

Actual Study Start Date :

Apr 2, 2020

Anticipated Primary Completion Date :

Oct 1, 2023

Anticipated Study Completion Date :

Jan 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Ureteroscopy	Procedure: 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). Other Names: URS
Percutaneous Nephrolithotomy	Procedure: 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). Other Names: PCNL
Shock Wave Lithotripsy	Procedure: 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 Names: SWL

Arm

Intervention/Treatment

Ureteroscopy

Procedure: 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).

Other Names:

URS

Percutaneous Nephrolithotomy

Procedure: 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).

Other Names:

PCNL

Shock Wave Lithotripsy

Procedure: 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 Names:

SWL

Outcome Measures

Primary Outcome Measures

Stone clearance [6 weeks post-op +/- 2 weeks]
Presence or absence of kidney stones will be assessed via post-operative clinically-indicated renal bladder ultrasound.

Secondary Outcome Measures

Patient-Reported Outcomes [Immediate impact (within 7 days) and delayed impact (up to 90 days) after surgery]
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.
Patients' Experiences [Immediate impact (within 7 days) and delayed impact (up to 90 days) after surgery]
Investigators will examine Heterogeneity of Treatment Effect (HTE) by age and sex and identify modifiable surgical techniques that impact patient experiences for each surgery.
Patients' Experiences [Up to 90 days after surgery]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

8 Years to 21 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Children's of Alabama	Birmingham	Alabama	United States	35233
2	Children's Hospital Los Angeles	Los Angeles	California	United States	90027
3	UCLA Mattel Children's Hospital	Los Angeles	California	United States	90095
4	Children's Hospital Colorado	Aurora	Colorado	United States	80045
5	Nemours A. I. duPont Hospital for Children	Wilmington	Delaware	United States	19803
6	Children's National Health System	Washington	District of Columbia	United States	20010
7	University of Florida Health Shands Children's Hospital	Gainesville	Florida	United States	32608
8	Nemours Children's Specialty Care	Jacksonville	Florida	United States	32207
9	AdventHealth Orlando	Orlando	Florida	United States	32803
10	Nemours Children's Hospital	Orlando	Florida	United States	32827
11	Children's Hospital of Atlanta	Atlanta	Georgia	United States	30322
12	Ann & Robert H. Lurie Children's Hospital of Chicago	Chicago	Illinois	United States	60611
13	Riley Hospital for Children	Indianapolis	Indiana	United States	46204
14	University of Kentucky	Lexington	Kentucky	United States	40506
15	Boston Children's Hospital	Boston	Massachusetts	United States	02115
16	University of Michigan	Ann Arbor	Michigan	United States	48109
17	St. Louis Children's Hospital	Saint Louis	Missouri	United States	63110
18	Cohen Children's Medical Center	New York	New York	United States	11040
19	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio	United States	45229
20	Nationwide Children's Hospital	Columbus	Ohio	United States	43205
21	University of Oklahoma Health Sciences Center	Oklahoma City	Oklahoma	United States	73104
22	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania	United States	19104
23	University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104
24	Monroe Carell Jr. Children's Hospital at Vanderbilt	Nashville	Tennessee	United States	37232
25	Children's Medical Center of Dallas	Dallas	Texas	United States	75235
26	Texas Children's Hospital	Houston	Texas	United States	77030
27	Primary Children's Hospital	Salt Lake City	Utah	United States	84113
28	Children's Hospital of Richmond at VCU	Richmond	Virginia	United States	23219
29	Seattle Children's Hospital	Seattle	Washington	United States	98105
30	Children's Wisconsin	Milwaukee	Wisconsin	United States	53226
31	The Hospital for Sick Children	Toronto	Ontario	Canada	M5G 1X8