Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT04285658
Previous Study | Return to List | Next Study

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 : April 3, 2020
Sponsor:
Collaborator:
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
Children's Hospital of Philadelphia

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
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 20 pediatric healthcare systems (22 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.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 1290 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pediatric KIDney Stone (PKIDS) Care Improvement Network
Actual Study Start Date : April 2, 2020
Estimated Primary Completion Date : October 2022
Estimated Study Completion Date : January 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Stones

Group/Cohort 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 Name: 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 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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



Information from the National Library of Medicine

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.


Layout table for eligibility information
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
Study Population
Pediatric patients in the United States receiving clinical care for kidney stones at a medical facility in the PKIDS Network.
Criteria

Inclusion Criteria:

  1. 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.
  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:

  1. 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.
  2. Parent/guardians or patients, who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures

Information from the National Library of Medicine

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


Contacts
Layout table for location contacts
Contact: Director of PKIDS Operations 215-516-9697 pkids@email.chop.edu

Locations
Show Show 22 study locations
Sponsors and Collaborators
Children's Hospital of Philadelphia
Patient-Centered Outcomes Research Institute

Layout table for additonal information
Responsible Party: Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT04285658    
Other Study ID Numbers: 19-016832
CER-2018C3-14778 ( Other Grant/Funding Number: Patient-Centered Outcomes Research Institute )
First Posted: February 26, 2020    Key Record Dates
Last Update Posted: April 3, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Children's Hospital of Philadelphia:
kidney
kidney stone
nephrolithiasis
Comparative Effectiveness
Patient Reported Outcomes
Additional relevant MeSH terms:
Layout table for MeSH terms
Kidney Calculi
Nephrolithiasis
Calculi
Pathological Conditions, Anatomical
Kidney Diseases
Urologic Diseases
Urolithiasis
Urinary Calculi