Renal SWE as a Predictor After Pediatric Pyeloplasty for UPJO
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age6-18
SponsorBeni-Suef University
About this trial
Ureteropelvic junction obstruction is an important cause of hydronephrosis and potentially reversible renal functional impairment in children. Although open pyeloplasty is an effective standard treatment, the degree of postoperative renal functional recovery varies between patients.
This prospective observational cohort study will evaluate whether renal cortical shear wave elastography can predict renal functional recovery after open pyeloplasty in children with unilateral primary ureteropelvic junction obstruction. Renal cortical shear wave elastography will be assessed before surgery and during follow-up, and the change in elastography values will be compared with renal isotope findings after surgery.
The primary objective is to evaluate the predictive value of the change in renal cortical shear wave elastography from baseline to 3 months after surgery for isotope-defined renal functional recovery at 6 months after open pyeloplasty.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Children aged 6 months to 18 years.
Diagnosis of unilateral primary ureteropelvic junction obstruction.
Planned for open dismembered pyeloplasty.
Availability of preoperative renal ultrasonography, renal cortical shear wave elastography, and diuretic renography.
Disqualifiers
Bilateral ureteropelvic junction obstruction.
Secondary ureteropelvic junction obstruction.
Previous ipsilateral upper urinary tract surgery.
Associated major urinary tract anomalies likely to independently affect renal function, including vesicoureteral reflux, megaureter, duplex system, posterior urethral valves, or ectopic kidney.
Trial population
Children aged 6 months to 18 years with unilateral primary ureteropelvic junction obstruction who are scheduled for open dismembered pyeloplasty at the Department of Urology, Faculty of Medicine, Beni-Suef University.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
84 Participants
are grouped into 1 trial groupGroup A: Children With Unilateral UPJO Undergoing Open Pyeloplasty
Trial outcomes
Primary outcomes
1
Predictive Accuracy of 3-Month Change in Renal Cortical SWE for 6-Month Functional Recovery
The change in renal cortical shear wave elastography from baseline to 3 months after open pyeloplasty will be evaluated for its ability to predict renal functional recovery at 6 months.
Time frame
Baseline to 6 months after open pyeloplastySecondary outcomes
1
Association Between 3-Month Renal Cortical SWE and 6-Month Functional Recovery
The association between the renal cortical shear wave elastography value measured at 3 months after open pyeloplasty and renal functional recovery at 6 months will be assessed.
Time frame
3 months to 6 months after open pyeloplasty2
Association Between 6-Month Change in Renal Cortical SWE and 6-Month Isotope Findings
The change in renal cortical shear wave elastography from baseline to 6 months after open pyeloplasty will be assessed in relation to 6-month renal isotope findings.
Time frame
Baseline to 6 months after open pyeloplasty3
Longitudinal Change in Renal Cortical SWE After Pyeloplasty
Renal cortical shear wave elastography values will be compared over time at baseline, 3 months, and 6 months after open pyeloplasty to assess postoperative changes in renal
Time frame
Baseline, 3 months, and 6 months after open pyeloplasty.Other outcomes
1
Change in Ultrasonographic Anteroposterior Pelvic Diameter
Anteroposterior pelvic diameter of the affected kidney will be measured by renal ultrasonography before surgery and during postoperative follow-up to assess improvement in hydronephrosis.
Time frame
Baseline, 3 months, and 6 months after open pyeloplastySponsors and contacts
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Source ClinicalTrials.gov