Elastographic Analysis of Urothelial Bladder Tumours
- Conditions
- Elastographic MeasurementIntravesical Pressure Measurement
- Interventions
- Procedure: urethral bladder resection
- Registration Number
- NCT06225726
- Lead Sponsor
- University Hospital, Tours
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 50
- 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
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Experimental : Urothelial bladder tumour urethral bladder resection Patient with an indication of transurethral resection of the bladder. Following the Urology consultation, the patient will be called for a trans-urethral bladder resection within 1 month. The patient will be admitted to the Urology Department of the Tours University Hospital the previous day.
- Primary Outcome Measures
Name Time Method Ultrasound elastography measurements 10 minutes, during surgery Measure of tumoral ultrasound elasticity (in kPa) with an abdominal ultrasound transducer.
- Secondary Outcome Measures
Name Time Method Comparison between ultrasound results and histology through study completion, an average of 10 months Histology criteria : tumoral grade according to WHO classification (1973 and 2022)
Comparison between ultrasound results and cystometry through study completion, an average of 10 months Cystometry data using an urodynamic system during the cystoscopy and simultaneous ultrasound measurements at successive filling volumes : intravesical pressure (cmH2O).
Trial Locations
- Locations (1)
University hospital
🇫🇷Tours, France