Elastographic Analysis of Urothelial Bladder Tumours. Correlation of Elastography With Urodynamic Study and Tumour Grade
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Ultrasound elastography measurements
研究概览
简要总结
The preoperative evaluation of bladder tumors includes either computed tomography, magnetic resonance imaging in B-mode, or a cystoscopy in the absence of a radiological diagnosis. The diagnosis is confirmed after a transurethral resection of the bladder (TURB) and a histopathological analysis.
Ultrasound is a non-invasive imaging technique that uses high-frequency sound waves to produce images of internal structures. Conventional ultrasound in B-mode can only provide details about the tumor's number, size, and location.
Elastography uses ultrasound imaging techniques to examine the stiffness of a tissue. Using the Aixplorer system many recently published papers suggested that ShearWave Elasticity (SWE) imaging, enables the differentiation of low- from high-grade breast tumors by assessing the elasticity of the tissue.
Investigators intend to evaluate the stiffness of bladder tumors with ultrasound elastography in comparison with cystometry parameters and tumoral grade.
详细描述
According to European and French guidelines, Transurethral resection of the bladder can be followed by an administration of early postoperative intravesical chemotherapy. This treatment is indicated in the absence of presumed high grade tumor (preoperative high grade cytology) and in the absence of post-operative haematuria and bladder perforation. Unfortunately, urine cytology has a sensitivity for the detection of high-grade tumour of only 50%. Therefore, it is essential to predict more precisely the bladder tumor grade.
Ultrasound is a non-invasive imaging technique that uses high-frequency sound waves to produce images of internal structures. Conventional ultrasound in B-mode can only provide details about the tumor's number, size, and location.
Elastography uses ultrasound imaging techniques to examine the stiffness of a tissue. Using the Aixplorer system many recently published papers suggested that ShearWave Elasticity (SWE) imaging, enables the differentiation of low- from high-grade breast tumors by assessing the elasticity of the tissue. Many studies have shown a significant correlation between ultrasound elastography of the bladder wall with measurements of the detrusor pressure. Only one study, conducted by Huang et al., have assessed its application in the evaluation of bladder cancer with an intraluminal transducer. A significant difference between elasticity of low grade and high grade bladder tumors was found. However, no data on the impact of the intravesical volume over the tumoral elasticity is available.
The objective of this project is to evaluate the correlation between the ultrasound Elastography of urothelial bladder tumors with their tumoral grade before transurethral resection of the bladder.
Knowing that ultrasound Elastography is impacted by the pressure applied to a tissue, investigators intend to measure the tumoral elasticity - with an abdominal ultrasound transducer - during bladder filling with a monitoring of the intravesical pressure.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years
- •Bladder tumour visualised on abdominal ultrasound or estimated to be more than 2 cm in diameter by fibroscopy or CT scan
- •Primary resection
排除标准
- •BMI > 30 kg/m2,
- •Bladder catheterisation,
- •Previous bladder or prostate surgery,
- •Previous intravesical instillation (BCG / Ametycine)
- •Previous pelvic radiotherapy,
- •Person having objected to data processing.
结局指标
主要结局
Ultrasound elastography measurements
时间窗: 10 minutes, during surgery
Measure of tumoral ultrasound elasticity (in kPa) with an abdominal ultrasound transducer.
次要结局
- Comparison between ultrasound results and histology(through study completion, an average of 10 months)
- Comparison between ultrasound results and cystometry(through study completion, an average of 10 months)