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.
Descripción general del estudio
Estado
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Hany F Badawy, MD
- Número de teléfono: +201149525028
- Correo electrónico: HANYFATHY86@GMAIL.COM
Copia de seguridad de contactos de estudio
- Nombre: Ghada S Etman, MD
- Número de teléfono: +201211874080
- Correo electrónico: Drhanyfathy86@GMAIL.COM
Ubicaciones de estudio
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Beni Suweif Governorate
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Banī Suwayf, Beni Suweif Governorate, Egipto
- Reclutamiento
- Department of Urology- Beni-Suef University Hospitals
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Contacto:
- Hany F Badawy, MD
- Número de teléfono: +201149525028
- Correo electrónico: HANYFATHY86@GMAIL.COM
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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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.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Predictive Accuracy of 3-Month Change in Renal Cortical SWE for 6-Month Functional Recovery
Periodo de tiempo: Baseline to 6 months after open pyeloplasty
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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.
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Baseline to 6 months after open pyeloplasty
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Association Between 3-Month Renal Cortical SWE and 6-Month Functional Recovery
Periodo de tiempo: 3 months to 6 months after open pyeloplasty
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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.
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3 months to 6 months after open pyeloplasty
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Association Between 6-Month Change in Renal Cortical SWE and 6-Month Isotope Findings
Periodo de tiempo: Baseline to 6 months after open pyeloplasty
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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.
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Baseline to 6 months after open pyeloplasty
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Longitudinal Change in Renal Cortical SWE After Pyeloplasty
Periodo de tiempo: Baseline, 3 months, and 6 months after open pyeloplasty.
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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
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Baseline, 3 months, and 6 months after open pyeloplasty.
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Change in Ultrasonographic Anteroposterior Pelvic Diameter
Periodo de tiempo: Baseline, 3 months, and 6 months after open pyeloplasty
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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.
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Baseline, 3 months, and 6 months after open pyeloplasty
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Hany F Badawy, Faculty of medicine, BeniSuef University
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- FMBSUREC05052026BadawySWE
- FMBSUREC/05052026/Badawy (Otro identificador: FM-BSU REC)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
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