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临床试验/NCT05592457
NCT05592457招募中不适用

Role of Non-contrast MDCT in the Assessment of Upper Urinary Tract Calculi Post ESWL to Predict Its Success Rate

Assiut University1 个研究点 分布在 1 个国家目标入组 55 人开始时间: 2022年10月15日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
55
试验地点
1
主要终点
ct follow up during swl

研究概览

简要总结

Urinary stones are a common disease affecting one in 11 people . Their clinical presentation varies from being silent to severe loin pain owing to urinary obstruction. Currently, ESWL is the treatment of choice for most renal calculi ⩽30 mm, with success rates of 60-99%. Although many treatment options exist, ESWL has the advantages of simplicity and non-invasiveness. In contrast, failure of a first ESWL attempt requires a follow-up ESWL procedure, or an alternative procedure, both of which increase medical costs.

Advancements in imaging have significantly contributed to this process. In the mid- 1990s, computed tomography (CT) began to replace intravenous urography (IVU), abdominal films (KUB), and ultrasound (US) in stone diagnosis. Studies demonstrated that CT had superior sensitivity and specificity for stone diagnosis compared to the aforementioned modalities. Now non-contrast multidetector CT (NC-MDCT) is the gold standard for the detection of urinary system calculi. CT is also clinically useful as it can show alternate renal and non-renal pathology if present.

Many factors have been reported to predict ESWL outcome, such as skin-to-stone distance (SSD), stone size, stone location, multiplicity, the energy used, and Hounsfield Unit (HU) values measured by non-contrast computed tomography (NCCT).

详细描述

Excellent fragmentation results are produced using ESWL. However, the retention of post-ESWL fragments in the kidney continues to be a significant medical issue. Only 32% of calcium stone patients in research were found to remain stone-free for 12 months following ESWL, according to the results. As a result, it appears that fragment growth and persistence are frequent after ESWL [10].

The first ESWL residual that is accessible must undergo a thorough stone analysis to properly carry out the subsequent treatments to prevent relapse or recurrent stone because stone-free rates after ESWL are directly connected to stone placement, size, number, and composition

研究设计

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

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients older than 18 years.
  • stone size up to 25 mm for renal pelvic stones and up to 15 mm for upper ureteric stones.
  • SSD < 11 cm.

排除标准

  • any patient with contraindications to ESWL as
  • uncontrolled urinary infection.
  • clotting alterations.
  • aortic or renal artery aneurysm.
  • pregnancy.
  • serious skeletal malformations.
  • serious obesity and or contraindications to CT as pregnancy.

结局指标

主要结局

ct follow up during swl

时间窗: 3 weeks

Correlation between the stone density before and during ESWL sessions to determine if this predicts the success prevent new ESWL.

stone Hounsfield

时间窗: 3weeks

Determine the role of the density of the residual stone fragments in the prediction of the complication during ESWL.

次要结局

  • density of stone and other factors(3weeks)

研究者

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

Dina Essam

principle investigator

Assiut University

研究点 (1)

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