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.
Обзор исследования
Статус
Подробное описание
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.
Тип исследования
Регистрация (Оцененный)
Контакты и местонахождение
Контакты исследования
- Имя: Hany F Badawy, MD
- Номер телефона: +201149525028
- Электронная почта: HANYFATHY86@GMAIL.COM
Учебное резервное копирование контактов
- Имя: Ghada S Etman, MD
- Номер телефона: +201211874080
- Электронная почта: Drhanyfathy86@GMAIL.COM
Места учебы
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Beni Suweif Governorate
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Banī Suwayf, Beni Suweif Governorate, Египет
- Рекрутинг
- Department of Urology- Beni-Suef University Hospitals
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Контакт:
- Hany F Badawy, MD
- Номер телефона: +201149525028
- Электронная почта: HANYFATHY86@GMAIL.COM
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Ребенок
- Взрослый
Принимает здоровых добровольцев
Метод выборки
Исследуемая популяция
Описание
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.
Учебный план
Как устроено исследование?
Детали дизайна
Когорты и вмешательства
Группа / когорта |
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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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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
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Predictive Accuracy of 3-Month Change in Renal Cortical SWE for 6-Month Functional Recovery
Временное ограничение: 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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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Association Between 3-Month Renal Cortical SWE and 6-Month Functional Recovery
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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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Другие показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
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Change in Ultrasonographic Anteroposterior Pelvic Diameter
Временное ограничение: 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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Соавторы и исследователи
Спонсор
Следователи
- Главный следователь: Hany F Badawy, Faculty of medicine, BeniSuef University
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- FMBSUREC05052026BadawySWE
- FMBSUREC/05052026/Badawy (Другой идентификатор: FM-BSU REC)
Планирование данных отдельных участников (IPD)
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Описание плана IPD
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
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