Renal SWE as a Predictor After Pediatric Pyeloplasty for UPJO

NCT07624019 | Recruiting

• 2 other identifiers: FMBSUREC05052026BadawySWEFMBSUREC/05052026/Badawy
• Study Type: observational
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

Renal Functional Recovery; Ureteropelvic Junction Obstruction

Keywords

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

Outcome Measures

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.

  Baseline to 6 months after open pyeloplasty

Secondary Outcomes (3)

• Association Between 3-Month Renal Cortical SWE and 6-Month Functional Recovery

  3 months to 6 months after open pyeloplasty

• Association Between 6-Month Change in Renal Cortical SWE and 6-Month Isotope Findings

  Baseline to 6 months after open pyeloplasty

• Longitudinal Change in Renal Cortical SWE After Pyeloplasty

  Baseline, 3 months, and 6 months after open pyeloplasty.

Other Outcomes (1)

• Change in Ultrasonographic Anteroposterior Pelvic Diameter

  Baseline, 3 months, and 6 months after open pyeloplasty

Study Arms (1)

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.

Eligibility Criteria

• Age: 6 Months - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beni-Suef University: lead

Study Sites (1)

Department of Urology- Beni-Suef University Hospitals

Banī Suwayf, Beni Suweif Governorate, Egypt

RECRUITING

MeSH Terms

Conditions

Multicystic renal dysplasia, bilateral

Study Officials

• Hany F Badawy

  Faculty of medicine, BeniSuef University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hany F Badawy, MD

CONTACT

+201149525028; HANYFATHY86@GMAIL.COM

Ghada S Etman, MD

CONTACT

+201211874080; Drhanyfathy86@GMAIL.COM

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Urology, Faculty of Medicine, Beni-Suef University

Study Record Dates

• First Submitted: May 28, 2026
• First Posted: June 3, 2026
• Study Start: May 6, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: June 3, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)