Pediatric KIDney Stone (PKIDS) Care Improvement Network (PKIDS)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04285658|
Recruitment Status : Recruiting
First Posted : February 26, 2020
Last Update Posted : August 16, 2022
- Study Details
- Tabular View
- No Results Posted
- How to Read a Study Record
|Condition or disease||Intervention/treatment|
|Kidney Stone Nephrolithiasis||Procedure: Ureteroscopy Procedure: Percutaneous Nephrolithotomy Procedure: Shock Wave Lithotripsy|
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.
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 :||Observational|
|Estimated Enrollment :||1290 participants|
|Official Title:||Pediatric KIDney Stone (PKIDS) Care Improvement Network|
|Actual Study Start Date :||April 2, 2020|
|Estimated Primary Completion Date :||October 2023|
|Estimated Study Completion Date :||January 2024|
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 Name: URS
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 Name: 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 Name: SWL
- 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.
- Patient-Reported Outcomes [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||8 Years to 21 Years (Child, Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
|Sampling Method:||Non-Probability Sample|
- 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.
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04285658
|Contact: Director of PKIDS Operationsemail@example.com|
|Responsible Party:||Children's Hospital of Philadelphia|
|Other Study ID Numbers:||
CER-2018C3-14778 ( Other Grant/Funding Number: Patient-Centered Outcomes Research Institute )
|First Posted:||February 26, 2020 Key Record Dates|
|Last Update Posted:||August 16, 2022|
|Last Verified:||August 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Undecided|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Patient Reported Outcomes
Pathological Conditions, Anatomical
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Male Urogenital Diseases