NCT03137953

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: HealthCare Global Enterprise Ltd. · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Buccal Mucosa Cancer
• Gingival Cancer

Interventions

Type	Name	Description
PROCEDURE	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.
DIAGNOSTIC_TEST	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.

Timeline

• Start date: 2016-06-01
• Primary completion: 2017-06-30
• Completion: 2017-06-30
• First posted: 2017-05-03
• Last updated: 2017-05-09

Locations

1 site across 1 country: India