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NCT Number: NCT07624019

Renal SWE as a Predictor After Pediatric Pyeloplasty for UPJO

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.

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Key information

Age range

6 month–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Urology- Beni-Suef University Hospitals

Banī Suwayf, Beni Suweif Governorate, Egypt

Location status: Recruiting

Location contact

Hany F Badawy, MD

CONTACT

[email protected]

+201149525028

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Predictive Accuracy of 3-Month Change in Renal Cortical SWE for 6-Month Functional Recovery

    Time frame: Baseline to 6 months after open pyeloplasty

    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.

Secondary outcomes

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

    Time frame: 3 months to 6 months after open pyeloplasty

    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.

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

    Time frame: Baseline to 6 months after open pyeloplasty

    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.

  3. Longitudinal Change in Renal Cortical SWE After Pyeloplasty

    Time frame: Baseline, 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

Other outcomes

  1. Change in Ultrasonographic Anteroposterior Pelvic Diameter

    Time frame: Baseline, 3 months, and 6 months after open pyeloplasty

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ghada S Etman, MD

CONTACT

[email protected]

+201211874080

Hany F Badawy, MD

CONTACT

[email protected]

+201149525028

Sponsors and collaborators

Lead sponsor

Beni-Suef University

Other

Registry information

Official study title

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

Acronym: UPJO-SWE

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 3, 2026
Registry last updated
Jun 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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