跳至主要内容
临床试验/NCT02035735
NCT02035735已完成不适用

Usefulness of Narrow-band Imaging to Estimate the Superficial Spread of Squamous Cell Carcinomas in Oropharynx, Hypopharynx and Larynx

University Hospital, Toulouse2 个研究点 分布在 1 个国家目标入组 93 人开始时间: 2014年1月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
93
试验地点
2
主要终点
Number of patients for whom superficial extension of the tumors has been increased by NBI.

研究概览

简要总结

The aim of this study is to prospectively determine if the use of NBI endoscopy modifies the superficial extension of these tumors.

详细描述

Several studies have already showed the interest of the use of NBI for the early diagnosis of malignancies of the upper aerodigestive tract. For all tumors, the most accurate evaluation of its limits is very important to perform the best strategy of treatment. If surgery seems to be the best option, surgical margins must be widely healthy. Despite the systematic transnasal flexible endoscopy with white lamp followed by laryngoscopy under general anesthesia (LGA) and tomodensitometric evaluation, surgical margins can be unhealthy (in situ carcinoma or dysplasia). We propose to evaluate if the use of the NBI could be useful to determine the superficial spread of squamous cell carcinomas in these locations.

To April 2013 to Mars 2015, all patients with a suspicion of squamous cell carcinoma of the oropharynx, hypopharynx or larynx and whom a LGA are expected, are included. The day before the LGA, two endoscopies by two different physicians were performed for each patients and recorded: the first one with white light and the second one with NBI. All results are noted on a schema. Superficial extension or synchronous lesions showed by NBI are analysed and compared with with lamp technic.

After surgery, surgical margins were evaluated and healthy margins were measured.

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

入选标准

  • Patients who can benefit a laryngoscopic exam under general anesthesia

排除标准

  • General anesthesia contra-indications
  • Local anesthesia allergy
  • Breast-feeding period or pregnancy

研究组 & 干预措施

Videoendoscopy with WL and NBI

Experimental

The day before the laryngoscopy under general anesthesia (LGA), two endoscopies by two different physicians were performed for each patients and recorded: the first one with white light (WL) and the second one with NBI (NBI).

干预措施: WL and NBI (Procedure)

结局指标

主要结局

Number of patients for whom superficial extension of the tumors has been increased by NBI.

时间窗: 4 minutes

次要结局

  • Number of tumors upstaged.(4 minutes)
  • Contribution of the NBI in the diagnosis of pre-neoplastic lesions.(4 minutes)
  • Contribution of the NBI in the evaluation of surgical margins.(4 minutes)
  • Contribution of the NBI in the diagnosis of other synchronous locations.(4 minutes)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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