The Diagnosis of the Squamous Cell Carcinoma in Head and Neck by Using the Probe-based Confocal Laser Endomicroscopy
试验速览
- 阶段
- 不适用
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- pCLE classification and scoring system
研究概览
简要总结
To evaluate the use of probe-based confocal laser endomicroscopy (pCLE) in human nasopharyngeal mucosa for the differentiation of the nasopharyngeal squamous cell carcinomas.
详细描述
The aim of this study was to depict the applicability of pCLE examinations for diagnosing NPC in comparison to the gold standard of histopathological examination, as well as developed an easy-to-use and straightforward scoring system for the identification of NPC on the basis of morphological and architectural criteria in order to enable a valid and reproducible CLE assessment even for non-experts in their daily clinical practice.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female > 18 years of age
- •Indicated for nasal endoscope for indeterminate NPC
- •Willing and able to comply with study procedures and provide written informed consent to participate in the study
排除标准
- •Subjects for whom pCLE procedures are contraindicated
- •Known allergy to fluorescein dye
- •If female, pregnant based on a positive hCG serum or an in vitro diagnostic test result or breast-feeding
研究组 & 干预措施
normal mucosa
Flat and relatively uniform polygonal epithelial cells with alternating dark and light bands were noted in pCLE images of normal mucosa after intravenous injecting 10% fluorescein.
干预措施: 10% fluorescein (Diagnostic Test)
lymphoid hyperplasia
An unorganized tissue architecture, irregular cells (difference of cell shape, color and size), slightly intensified fluorescein leakage, and vessels not assessable were found in the lymphoid hyperplasia of nasopharyngeal mucosa after intravenous injecting 10% fluorescein..
干预措施: 10% fluorescein (Diagnostic Test)
nasopharyngeal carcinoma
pCLE images of nasopharyngeal carcinoma, which was associated with crowded unorganized tissue architecture (a dark-gray background without identification of mucosal structures), irregular cells like cell clusters, amplified fluorescein leakage, and irregular vessels changes after intravenous injecting 10% fluorescein.
干预措施: 10% fluorescein (Diagnostic Test)
结局指标
主要结局
pCLE classification and scoring system
时间窗: 3 months
Evaluation of pCLE diagnostic performance for the diagnosis of NPC when associated with other diagnostic information.
次要结局
- the quantitative image analysis(3 months)
研究者
Huawei Li, Ph.D, MD
Director of Otorhinolaryngology Department of Affiliated Eye and ENT Hospital, Fudan University
Eye & ENT Hospital of Fudan University