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临床试验/NCT02878148
NCT02878148已完成不适用

Conditional Imaging Prescription Strategy as an Alternative to Systematic Unenhanced Computed Tomography for Exploration of Acute Uncomplicated Renal Colic With Lower Radiation Exposure

University Hospital, Montpellier2 个研究点 分布在 1 个国家目标入组 220 人开始时间: 2016年10月17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
220
试验地点
2
主要终点
Diagnostic performances (sensitivity,specificity, calculated according to the tested conditional strategies imaging modality)

研究概览

简要总结

Prospective single centre study aiming at validating a conditional imaging strategy for diagnosis of suspected kidney stone.

Consecutive Emergency department patients referred to the medical imaging department for exploration of a suspected acute uncomplicated renal colic will undergo the following interventions : systematic plain abdominal Xray, systematic ultrasonography and systematic unenhanced CT (with a reduced dose scan), in addition to clinical examination and assessment of body mass index and the Sex, Timing, Origin, Nausea, Erythrocytes (STONE) clinical prediction score for symptomatic stone.

Patients will be followed up at 1 month to record the need for urologic intervention and its type.

The performances of different conditional imaging strategy for the diagnosis of suspected renal colic will be assessed retrospectively. The conditional strategies tested will be based on the patient's stone score and BMI and targeted use of combined plain X-ray and ultrasonography and/or unenhanced CT.

The reference diagnosis for renal colic will be made according to the finding of a ureteral stone or indirect signs of urolithiasis at unenhanced CT.

详细描述

Plain abdominal Xray, Ultrasonography and unenhanced CT of the abdomen and pelvis will be performed at the time of admission to the imaging department, within 2 days from ED visit and within a 1 hour delay from each other.

Ultrasonography will be interpretated in combination to plain abdominal Xray, and independently from unenhanced CT, by two experienced radiologists blinded to the results of each other.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

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

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Diagnostic performances (sensitivity,specificity, calculated according to the tested conditional strategies imaging modality)

时间窗: Baseline

Different conditional strategies will be evaluated a posteriori based on the targeted use or not of ultrasonography combined to plain X-ray and/or unenhanced CT, according to the patient's STONE score and BMI. The reference diagnosis for renal colic will be made according to the finding of a ureteral stone or indirect signs of urolithiasis at unenhanced CT (gold standard imaging modality)

次要结局

  • Radiation exposure dose according to the different imaging strategies tested(Baseline)
  • Diagnostic performances of the tested conditional strategies for alternative diagnosis(Baseline)
  • Diagnostic performances of the tested conditional strategies for the diagnosis of ureteral stone in patients with urethral stone who benefited from urologic management(Baseline)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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