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临床试验/NCT05852665
NCT05852665尚未招募不适用

Ultrasound-guided Resection of Buccal Mucosal Carcinomas - a Multicenter Study

UMC Utrecht0 个研究点目标入组 50 人开始时间: 2023年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
UMC Utrecht
入组人数
50
主要终点
Number of involved margins

研究概览

简要总结

The aim of this research is to decrease the number of inadequate tumor-free margins, probably resulting in less adjuvant therapy, less local recurrences and better quality of life.

详细描述

Buccal mucosa cancer is a rare disease. In the Netherlands, approximately 100 patients are treated for this disease each year. To obtain good local control, it is important that the histological distance from the tumor to the resection plane is 5 mm or more (tumor-free margin). If the tumor-free margin is smaller, such as close (1-5 mm) or involved (<1 mm) margins, there is usually an indication for adjuvant therapy. Now, the tumor-free margins in buccal mucosa cancer are often insufficient, so that a significant proportion of patients require adjuvant treatment (re-resection or radiotherapy). Postoperative radiotherapy can greatly reduce the quality of life due to the development of, for example, osteoradionecrosis, mucositis and fibrosis. During a re-resection it is often difficult to find the location of the insufficient margin. Ultrasound-guided resection can be used to visualize the tumor during surgery, in order to improve the tumor-free margins. Currently, the tumor-free margin is only estimated palpably and frozen sections are sometimes used in case of doubt.

The aim of this research is to decrease the number of involved margins, probably resulting in less adjuvant therapy, less local recurrences, and better quality of life.

In this trial, 50 patients with a squamous cell carcinoma of the buccal mucosa will be included for treatment with ultrasound-guided resection.

50 patients with a squamous cell carcinoma of the buccal mucosa, who will be treated with surgery under general anesthesia, will be included in this study. The tumor has to be visible as an hypo-echogenic region on the ultrasound.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
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

  • buccal mucosal squamous cell carcinoma
  • surgical removal under general anesthesia

排除标准

  • tumor is not visible on ultrasound as echolucent region

结局指标

主要结局

Number of involved margins

时间窗: within 2 weeks after surgery

Number of involved margins

次要结局

  • Quality of life assessed by questionnaires at 4 timepoints(before surgery, at 4, 8, and 12 months after surgery)
  • Sensitivity and specificity of ultrasound for identifying involved margins(within 2 weeks after surgery)
  • Number of patients with an indication for local adjuvant therapy(within one month after surgery)

研究者

发起方
UMC Utrecht
申办方类型
Other
责任方
Principal Investigator
主要研究者

Rob Noorlag

Principal Investigator

UMC Utrecht

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