Buccal Mucosa Cancer, Gingival Cancer
Conditions
Brief summary
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
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.
Interventions
PROCEDUREClinical 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.
DIAGNOSTIC_TESTRadiological 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.
Sponsors
HealthCare Global Enterprise Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients undergoing skin preservation surgeries | Data would be obtained on the day of Surgery | Proportion of subjects who are to undergo skin preservation surgeries |
Countries
India
Contacts
Primary ContactVishal US Rao, MS
Backup ContactSowjanya Gandla, MS
Outcome results
None listed