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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-01

Study Completion Date

2017-06-30

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.

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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.

Conditions

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Buccal Mucosa Cancer Gingival Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Clinical and Imaging

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.

Group Type EXPERIMENTAL

Clinical Evaluation

Intervention Type PROCEDURE

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.

Radiological Imaging

Intervention Type DIAGNOSTIC_TEST

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.

Interventions

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Clinical Evaluation

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.

Intervention Type PROCEDURE

Radiological Imaging

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.

Intervention Type DIAGNOSTIC_TEST

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