Confocal Laser Endomicroscopy During TransUrethral Resection for Improving Bladder Cancer Diagnosis and Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Diagnostic accuracy of flexible-probe based CLE(pCLE) for the diagnosis of urothelial carcinoma of the bladder (UCB)
研究概览
简要总结
A prospective monocenter diagnostic accuracy study of Confocal Laser Endomicroscopy (CLE) for Bladder Cancer(BC) to assess two primary objectives:
- The diagnostic accuracy of flexible probe-based confocal laser endomicroscopy (CLE) compared to histopathology of the resection specimen.
- The diagnostic accuracy of CLE-based assessment of the surgical radicality of the resection bed (radical vs irradical) in comparison with histopathology of a biopsy of the resection bed.
All patients with a papillary bladder tumor on cystoscopy will be included in this trial.
详细描述
Rationale:
Initial evaluation of gross hematuria consists of White Light Cystoscopy (WLC). Urine cytology combined with contrast imaging of the upper urothelial tract is performed when a bladder tumor is seen. Follow up of non-muscle invasive bladder carcinoma (NMIBC) after initial treatment consists of similar steps. When a suspected lesion is visualized, a transurethral resection of the bladder tumor (TURBT) is performed for therapeutic and diagnostic purposes. TURBT is considered to be the gold standard for diagnosis of urothelial carcinoma of the bladder (UCB). High recurrence rates of UCB after TURBT are reported, leading to repetitive surgery and high costs. In certain cases of high grade UCB a second look TURBT has proven to be beneficial after primary resection to ensure radical resection. Furthermore, recent research suggests that active surveillance for low-grade bladder tumors is safe. Confocal laser endomicroscopy (CLE), a high resolution optical imaging technique that can be used in combination with endo-urological procedures, seems promising to improve diagnosis of urothelial cancer, possibly without the need for immediate transurethral resection to obtain histological confirmation. CLE characteristics of UCB have been determined and validated using rigid probes, which are incompatible with flexible cystoscopes used for outpatient cystoscopies. With the present study, we aim to assess the diagnostic value of flexible probe based CLE for diagnosis and grading of UCB. Furthermore to possibly prevent second look TURBT in the future,an assessment of CLE features of the resection bed using a rigid CLE-probe will be performed.
Objective:
Primary objectives:
This study is two-fold and, therefore, has two primary objectives:
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
- 否
入选标准
- •Display a papillary bladder tumor on cystoscopy.
- •>18 years of age.
- •Has given written informed consent.
排除标准
- •Patients with a known allergy to fluorescein.
- •Pregnancy or lactating women.
结局指标
主要结局
Diagnostic accuracy of flexible-probe based CLE(pCLE) for the diagnosis of urothelial carcinoma of the bladder (UCB)
时间窗: Consensus panel within 12 months of start of study.
Diagnostic accuracy (sensitivity, specificity, negative predictive value and positive predictive value) of flexible probe based CLE for the diagnosis (low-grade malignant, high-grade malignant) of urothelial carcinoma of the bladder.
Diagnostic potential of probe based CLE for assessment of surgical radicality after transurethral resection of a bladder tumour (TURBT).
时间窗: Consensus panel within 12 months of start of study.
To investigate the diagnostic potential of CLE for the assessment of the surgical radicality (residual tumor/no residual tumor) after TURBT.
Diagnostic potential of probe based CLE for assessment of depth of resection after transurethral resection of a bladder tumour (TURBT).
时间窗: Consensus panel within 12 months of start of study.
To investigate the diagnostic potential of CLE for depth of resection (according to the tissue in the resection margin: urothelium, submucosa, m. detrusor or perivesical fatty tissue) after TURBT.
次要结局
- Computer aided assessment of pCLE images for diagnosis and grading of UCB(Within 24 months after starting study)
研究者
Prof.dr. H.P. Beerlage
Head of Department of Urology
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)