跳至主要内容
临床试验/NCT02841904
NCT02841904Unknown不适用

The Accuracy of Probe-based Confocal Laser Endomicroscopy Versus Conventional Endoscopic Biopsies for the Diagnosis of Superficial Bladder Neoplasia.

Herlev Hospital2 个研究点 分布在 1 个国家目标入组 189 人开始时间: 2018年6月最近更新:
适应症
干预措施

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

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

Other

CLE assessed by the pathologist

干预措施: Confocal LASER Endomicroscopy (Device)

Biopsy

Active Comparator

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sami Beji, MD

Medical doctor

Herlev Hospital

研究点 (2)

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