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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Buccal Mucosa Cancer, Gingival Cancer

Intervention / Treatment
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* Procedure: Clinical Evaluation
* Diagnostic Test: Radiological Imaging


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Interventional Model Description: Examination of the distance between the skin and the base of the tumour would be evaluated clinically (skin Pinch Test) and by CT/MRI with contrast. Post resection, histopathological examination of tumour margins would confirm if the base of the tumour is free or not. The proportion of cases where skin is preserved would be compared to the proportion of cases where skin would have been preserved based on clinical examination would be assessed.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Clinical and Imaging<br>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. | Procedure: Clinical Evaluation<br>* The skin pinch test would be done by three independent oncologists to assess ability for skin conservation. The decision for skin conservation would be taken by the surgeon intra-operatively based on clinical and radiological assessments.<br>Diagnostic Test: Radiological Imaging<br>* Computed Tomography or Magnetic Resonance Imaging would be done by a radiologist and used to measure the distance between tumor and skin which would guide the decision for skin presevation. The decision for skin conservation would be taken by the surgeon intra-operatively based on clinical and radiological assessments.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients undergoing skin preservation surgeries | Proportion of subjects who are to undergo skin preservation surgeries | Data would be obtained on the day of Surgery |