Renal SWE as a Predictor After Pediatric Pyeloplasty for UPJO (UPJO-SWE)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Ureteropelvic Junction Obstruction; Renal Functional Recovery

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.

• Study Type: Observational
• Enrollment (Estimated): 84

Contacts and Locations

• Study Contact: Name: Hany F Badawy, MD; Phone Number: +201149525028; Email: Hanyfathy86@gmail.com
• Study Contact Backup: Name: Ghada S Etman, MD; Phone Number: +201211874080; Email: Drhanyfathy86@GMAIL.COM

Study Locations

• Egypt
  • Beni Suweif Governorate
    • Banī Suwayf, Beni Suweif Governorate, Egypt
      • Recruiting
      • Department of Urology- Beni-Suef University Hospitals
      • Contact: Hany F Badawy, MD; Phone Number: +201149525028; Email: Hanyfathy86@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Children With Unilateral UPJO Undergoing Open Pyeloplasty; Children aged 6 months to 18 years with unilateral primary ureteropelvic junction obstruction scheduled for open dismembered pyeloplasty. Participants will undergo preoperative renal ultrasonography, renal cortical shear wave elastography, and renal isotope assessment, followed by postoperative clinical, ultrasound, shear wave elastography, and isotope follow-up according to the study protocol.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline to 6 months after open pyeloplasty

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 months to 6 months after open pyeloplasty
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.	Baseline to 6 months after open pyeloplasty
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	Baseline, 3 months, and 6 months after open pyeloplasty.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, 3 months, and 6 months after open pyeloplasty

Collaborators and Investigators

• Sponsor: Beni-Suef University
• Investigators: Principal Investigator: Hany F Badawy, Faculty of medicine, BeniSuef University

Study record dates

Study Major Dates

• Study Start (Actual): May 6, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): May 1, 2027

Study Registration Dates

• First Submitted: May 28, 2026
• First Submitted That Met QC Criteria: May 28, 2026
• First Posted (Actual): June 3, 2026

Study Record Updates

• Last Update Posted (Actual): June 3, 2026
• Last Update Submitted That Met QC Criteria: May 28, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Shear wave elastography; Open pyeloplasty; Ureteropelvic junction obstruction; Pediatric UPJO; Renal cortical stiffness
• Additional Relevant MeSH Terms: Multicystic renal dysplasia, bilateral
• Other Study ID Numbers: FMBSUREC05052026BadawySWE; FMBSUREC/05052026/Badawy (Other Identifier: FM-BSU REC)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared. Only aggregated, de-identified study results will be reported. Individual-level pediatric clinical and imaging data will remain confidential and will be accessible only to the study investigators and authorized regulatory or ethics committee representatives if required.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No