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Renal SWE as a Predictor After Pediatric Pyeloplasty for UPJO

Renal Cortical Shear Wave Elastography as a Predictor of Functional Recovery After Open Pyeloplasty for Unilateral Pediatric Ureteropelvic Junction Obstruction: A Prospective Cohort Study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07624019
Acronym
UPJO-SWE
Enrollment
84
Registered
2026-06-03
Start date
2026-05-06
Completion date
2027-05-01
Last updated
2026-06-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Renal Functional Recovery, Ureteropelvic Junction Obstruction

Keywords

Pediatric UPJO, Open pyeloplasty, Shear wave elastography, Renal cortical stiffness, Ureteropelvic junction obstruction

Brief summary

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.

Detailed description

This is a prospective longitudinal observational cohort study conducted at the Department of Urology, Faculty of Medicine, Beni-Suef University. The study will include children aged 6 months to 18 years with unilateral primary ureteropelvic junction obstruction who are scheduled for open dismembered pyeloplasty. Eligible children will undergo standard preoperative clinical assessment, laboratory investigations, renal ultrasonography, renal cortical shear wave elastography, and renal isotope assessment. Preoperative imaging will include renal ultrasonography to assess hydronephrosis, anteroposterior pelvic diameter, and renal cortical thickness. Renal cortical shear wave elastography will be performed to measure cortical stiffness in the affected kidney. Renal isotope assessment will include diuretic renography for differential renal function and drainage assessment, with renal cortical scintigraphy when clinically indicated according to the approved protocol. All included patients will undergo open dismembered pyeloplasty according to standard surgical principles. Postoperative follow-up will include clinical assessment, renal ultrasonography, and renal cortical shear wave elastography at 3 and 6 months. A repeat renal isotope study will be performed at 6 months after surgery to reassess differential renal function and drainage. The primary outcome is the predictive performance of the change in renal cortical shear wave elastography from baseline to 3 months postoperatively for 6-month isotope-defined renal functional recovery after pyeloplasty. Secondary outcomes include the association between 3-month postoperative shear wave elastography and functional recovery, longitudinal changes in shear wave elastography, postoperative changes in differential renal function and drainage parameters, and improvement in ultrasonographic parameters after pyeloplasty.

Interventions

None listed

Sponsors

Beni-Suef University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
6 Months to 18 Years
Healthy volunteers
No

Inclusion criteria

* 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. * Written informed consent obtained from parent or legal guardian.

Exclusion criteria

* 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. * Active urinary tract infection at the time of assessment. * Known intrinsic renal parenchymal disease unrelated to obstruction. * Inability to obtain reliable shear wave elastography measurements. * Incomplete planned follow-up.

Design outcomes

Primary

MeasureTime frameDescription
Predictive Accuracy of 3-Month Change in Renal Cortical SWE for 6-Month Functional RecoveryBaseline to 6 months after open pyeloplastyThe 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.

Secondary

MeasureTime frameDescription
Association Between 3-Month Renal Cortical SWE and 6-Month Functional Recovery3 months to 6 months after open pyeloplastyThe 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.
Association Between 6-Month Change in Renal Cortical SWE and 6-Month Isotope FindingsBaseline to 6 months after open pyeloplastyThe 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.
Longitudinal Change in Renal Cortical SWE After PyeloplastyBaseline, 3 months, and 6 months after open 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

Countries

Egypt

Contacts

CONTACTHany F Badawy, MD
HANYFATHY86@GMAIL.COM+201149525028
CONTACTGhada S Etman, MD
Drhanyfathy86@GMAIL.COM+201211874080
PRINCIPAL_INVESTIGATORHany F Badawy

Faculty of medicine, BeniSuef University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 4, 2026