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

HealthCare Global

Status: Unknown

Conditions: Gingival Cancer; Buccal Mucosa Cancer

Treatments: Procedure: Clinical Evaluation; Diagnostic Test: Radiological Imaging

Study type: Interventional

Funder types: Industry

Identifiers

NCT03137953

HCG/SX/002/2016

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 30 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Clinical and Imaging

Experimental group

Description:

Subjects in this arm would undergo clinical evaluation of skin involvement followed by Radiological Imaging (CT/MRI) based evaluation of the distance between the base of the tumor and the skin. Based on this distance, the skin would either be conserved or not during tumor resection.

Treatment:

Procedure: Clinical Evaluation

Diagnostic Test: Radiological Imaging