跳至主要内容
临床试验/NCT07506031
NCT07506031已完成不适用

Evaluating Shear Wave Elastography as a Predictor of Extracorporeal Shock Wave Lithotripsy Outcomes and Stone Composition in Children "A Prospective Study"

Beni-Suef University1 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2025年12月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
110
试验地点
1
主要终点
ESWL Success Rate

研究概览

简要总结

This prospective study aims to evaluate the role of shear wave elastography (SWE) as a non-invasive and radiation-free tool for predicting the success of extracorporeal shock wave lithotripsy (ESWL) in pediatric patients with renal stones. Currently, computed tomography (CT)-derived Hounsfield units (HU) are used to estimate stone hardness; however, repeated radiation exposure is a concern in children. SWE may provide an alternative method by assessing stone stiffness using ultrasound.

Pediatric patients under 18 years with renal stones (6-20 mm) scheduled for ESWL will be included. SWE measurements will be performed prior to treatment, and patients will be followed for 3 months to assess treatment outcomes. The primary outcome is ESWL success, while secondary outcomes include correlation between SWE and HU, number of ESWL sessions required, prediction of stone composition, and assessment of the relationship between SWE measurements and stone composition.

This study seeks to determine whether SWE can serve as a reliable predictor of ESWL outcomes, correlate with stone composition, and reduce the need for radiation-based imaging in children.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
1 Year 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Inclusion criteria:
  • Single Renal stones measured 6- 20 mm in maximal dimension.
  • ESWL will be planned as the first line of treatment.

排除标准

  • Patients with internal ureteral stent.
  • ureteral stones.
  • abnormal renal anatomies (pelvic kidney, horseshoe kidney, and rotational anomaly).
  • active UTI at time of ESWL.
  • coagulopathy .
  • Exclusion Criteria:

研究组 & 干预措施

Pediatric Patients Undergoing ESWL

Pediatric patients (<18 years) with renal stones (6-20 mm) undergoing extracorporeal shock wave lithotripsy (ESWL). All patients will undergo baseline shear wave elastography (SWE) assessment prior to treatment. Patients will be followed for 3 months to evaluate ESWL success and its correlation with SWE measurements, Hounsfield units (HU), and stone composition.

结局指标

主要结局

ESWL Success Rate

时间窗: 3 months with maximum 3 sessions ESWL

Treatment success defined as absence of stone fragments or presence of clinically insignificant residual fragments ≤2 mm on imaging, without symptoms, obstruction, or urinary tract infection.

次要结局

  • Secondary Outcomes Related to SWE and ESWL(Up to 3 months after ESWL)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mahmoud Abdallah

lecturer of urology faculty of medicine Beni Suef university

Beni-Suef University

研究点 (1)

Loading locations...

相似试验