The Accuracy of Probe-based Confocal Laser Endomicroscopy Versus Conventional Endoscopic Biopsies for the Diagnosis of Superficial Bladder Neoplasia.
试验速览
- 阶段
- 不适用
- 入组人数
- 189
- 试验地点
- 2
- 主要终点
- accordance between CLE and histology in flat bladder tumors
研究概览
简要总结
This study evaluates the accuracy of Confocal Laser Endomicroscopy (CLE) in the diagnostic of non-invasive flat and exophytic bladder neoplasia. CLE results are compared to histopathology results.
详细描述
Confocal Laser Endomicroscopy (CLE) is a technique which during endoscopic examination of the bladder (cystoscopy) gives magnified, microscopic-like images of tissues and cells, by inserting a laser fiber through the cystoscope. CLE aims to target biopsies during cystoscopy and reduce the number of biopsies, and the need for additional cystoscopies i general anesthesia.
This study evaluates the ability of CLE to assess tissue in the bladder. The ability to diagnose normal mucosa, inflammation and tumors of the bladder by the CLE is compared to the histopathological examination of selected tissues (biopsies).
Patients scheduled for cystoscopy with biopsies in general anesthesia are recruited for the study. After standard cystoscopy where suspicious mucosal areas are located and marked, A contrast agent (Fluorescein) is administrated intravenously. CLE fiber is introduced through the cystoscope and the marked mucosal areas are examined by direct contact with the laser fiber. The pathologist assesses the CLE video and registers the results. Biopsies are then taken from the selected, suspicious areas. The results of CLE assessment are compared with the histopathological results.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- Single (Investigator)
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
- •First time Transurethral Resection of Bladder (TURB) for bladder tumors under 3 cm
- •Suspicious mucosa / Carcinoma in situ
- •Recurrent pTa
- •Positive cytology with normal flexible cystoscopy
- •Control after Bacille Calmette Guérin (BCG) treatment
排除标准
- •Allergy to fluorescein
- •Pregnant and lactating women.
- •Renal failure (eGFR <20 ml / min)
研究组 & 干预措施
CLE
CLE assessed by the pathologist
干预措施: Confocal LASER Endomicroscopy (Device)
Biopsy
Histology assessed by the pathologist
干预措施: Confocal LASER Endomicroscopy (Device)
结局指标
主要结局
accordance between CLE and histology in flat bladder tumors
时间窗: An average of 18 months
Accordance between confocal laser endoscopy and conventional biopsy according to the evaluation of the pathologist in flat bladder neoplasia
Accordance between CLE and histology in exophytic bladder tumors
时间窗: An average of 18 months
Accordance between confocal laser endoscopy and conventional biopsy according to the evaluation of the pathologist in exophytic bladder neoplasia
次要结局
- Accordance between CLE assessed by the surgeon and histology.(An average of 18 months)
- Accordance between the per-operative evaluation of CLE of the pathologist and the surgeon(An average of 18 months)
研究者
Sami Beji, MD
Medical doctor
Herlev Hospital
