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

2026年5月28日 更新者：Hany Fathy Badawy, MD、Beni-Suef University

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.

研究概览

地位

招聘中

条件

详细说明

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.

研究类型

观察性的

注册 (估计的)

84

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

  • 埃及
    • Beni Suweif Governorate
      • Banī Suwayf、Beni Suweif Governorate、埃及
        • 招聘中
        • Department of Urology- Beni-Suef University Hospitals
        • 接触：

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 孩子
  • 成人

接受健康志愿者

不

取样方法

非概率样本

研究人群

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.

描述

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.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

队列和干预

团体/队列
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.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Predictive Accuracy of 3-Month Change in Renal Cortical SWE for 6-Month Functional Recovery
大体时间：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.
Baseline to 6 months after open pyeloplasty

次要结果测量

结果测量
措施说明
大体时间
Association Between 3-Month Renal Cortical SWE and 6-Month Functional Recovery
大体时间：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.
3 months to 6 months after open pyeloplasty
Association Between 6-Month Change in Renal Cortical SWE and 6-Month Isotope Findings
大体时间：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.
Baseline to 6 months after open pyeloplasty
Longitudinal Change in Renal Cortical SWE After Pyeloplasty
大体时间：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
Baseline, 3 months, and 6 months after open pyeloplasty.

其他结果措施

结果测量
措施说明
大体时间
Change in Ultrasonographic Anteroposterior Pelvic Diameter
大体时间：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.
Baseline, 3 months, and 6 months after open pyeloplasty

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Beni-Suef University

调查人员

  • 首席研究员：Hany F Badawy、Faculty of medicine, BeniSuef University

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年5月6日

初级完成 (估计的)

2027年4月1日

研究完成 (估计的)

2027年5月1日

研究注册日期

首次提交

2026年5月28日

首先提交符合 QC 标准的

2026年5月28日

首次发布 (实际的)

2026年6月3日

研究记录更新

最后更新发布 (实际的)

2026年6月3日

上次提交的符合 QC 标准的更新

2026年5月28日

最后验证

2026年5月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • FMBSUREC05052026BadawySWE
  • FMBSUREC/05052026/Badawy (其他标识符：FM-BSU REC)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

IPD 计划说明

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.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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