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临床试验/NCT01087060
NCT01087060已完成不适用

Does Hounsfield Unit (HU) Predict the Detection of Cystic Renal Malignancy of Complicated Renal Cysts?

Seoul National University Hospital1 个研究点 分布在 1 个国家目标入组 269 人开始时间: 1997年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
269
试验地点
1
主要终点
additional diagnostic criteria of CT to diagnose and predict the detection and recurrence of cystic RCC in the patients with complicated renal cysts

研究概览

简要总结

The aim of this study was to show additional diagnostic criteria of computed tomography (CT) scan to diagnose and predict the detection and recurrence of cystic renal cell carcinoma in the patients with complicated renal cysts. Furthermore, we would demonstrate the relationship between complicated renal cysts diagnosed by Bosniak system and some parameters of pathological results. The analysis about detection time of renal malignancy would help determine the practical guidelines of follow-up plan for complicated renal cysts.

详细描述

Even though there have been many trials and errors to enhance the diagnostic accuracy of CT scans for complicated cysts, the trial to obtain the enhanced accuracy using CT scan would be still valuable, when we consider its widespread use. A previous study demonstrated that the enhancement of HU with intravenous administration of contrast material on CT scan by 15 HU would be "almost always indicative of a pathologic process although not always a malignancy", another study showed the cut-off as 42 or 47 HU gap would be helpful in the prediction of renal malignancy.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

年龄范围
20 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All patients who were diagnosed as renal cysts
  • available serial follow-up data of CT scan
  • all CT imaging included non-enhanced (NEP), corticomedullary (CMP), and early excretory phase (EEP) scans. The scan delay times should range from 30 to 40 seconds for CMP scans and from 120 to 180 seconds for EEP scans.

排除标准

  • cases diagnosed by only US/MR
  • no serial CT images
  • cysts of autosomal dominant adult polycystic kidney disease
  • cysts less than 1cm in diameter (difficult to evaluate accurately)
  • follow-up period less than 1 yr in the patients who had no surgery

结局指标

主要结局

additional diagnostic criteria of CT to diagnose and predict the detection and recurrence of cystic RCC in the patients with complicated renal cysts

First, the primary outcomes is to determine cut-off values of maximal HU and the maximal gap of HU (HU of early excretory phase minus that of non-enhanced phase in CT scan)to predict the detection of renal malignancy. Some clinical factors (age, height, body weight, etc) were also included in the analysis. Second, the above-mentioned factors were included in the analysis of risk factors for recurrence of complicated renal cysts to determine the cut-off values.

次要结局

  • informative to determine the time of operation and which is better for a patient with a complicated cyst between partial or radical nephrectomy

研究者

申办方类型
Other

研究点 (1)

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