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临床试验/NCT03137953
NCT03137953Unknown不适用

Role of Imaging to Predict the Deep Surgical Margin in Gingivobuccal Complex Tumors

HealthCare Global Enterprise Ltd.2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2016年6月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
30
试验地点
2
主要终点
Proportion of patients undergoing skin preservation surgeries

研究概览

简要总结

In gingivobuccal complex tumors, the skin margin is assessed by palpation (skin pinch test). There is no objective method of assessment of skin margin. This study is to evaluate the role of computed tomography/MRI with contrast in assessing the deep surgical margin.

详细描述

The patients of buccal mucosa squamous cell carcinomas after histopathological confirmation are selected for the study. As a routine computed tomography imaging/MRI with contrast will be done preoperatively.

The involvement of the skin is assessed by the palpation (skin pinch test). In imaging, the distance between the base of the tumour and the skin of the cheek is measured. If the distance between the base of the tumour and the skin is more than 5mm, then the skin is spared and the tumour is excised with 5 mm margin, if the distance is less than 5mm, then the skin is excised along with the tumour. The specimen will be sent for histopathological examination, and the depth of invasion of the tumour is measured and the clearance of the deep surgical margin is assessed.

The difference between clinical examination and imaging and histopathological confirmation of the specimen in determining the number of cases where skin preservation is done is assessed.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients of buccal mucosa squamous cell carcinomas of stage 1,2 and 3 are included in the study
  • Patient of all age groups are included in the study
  • Both males and females are included in the study

排除标准

  • Patients with buccal mucosa carcinomas, in whom the tumour is involving/fungating through the skin.

结局指标

主要结局

Proportion of patients undergoing skin preservation surgeries

时间窗: Data would be obtained on the day of Surgery

Proportion of subjects who are to undergo skin preservation surgeries

次要结局

未报告次要终点

研究者

发起方
HealthCare Global Enterprise Ltd.
申办方类型
Industry
责任方
Principal Investigator
主要研究者

Vishal U S Rao

Senior Consultant

HealthCare Global Enterprise Ltd.

研究点 (2)

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