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

Not Applicable

• Conditions: Gingival Cancer; Buccal Mucosa Cancer
• Interventions: Procedure: Clinical Evaluation; Diagnostic Test: Radiological Imaging

• Registration Number: NCT03137953
• Lead Sponsor: HealthCare Global Enterprise Ltd.

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.

Study Timeline

• Study Start: 2016-06-01
• Study First Submitted: 2017-02-13
• Study First Submitted QC: 2017-04-28
• Status Verified: 2017-05
• Study First Posted: 2017-05-03
• Last Update Submitted: 2017-05-08
• Last Update Posted: 2017-05-09
• Primary Completion: 2017-06-30
• Study Completion: 2017-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Clinical and Imaging	Clinical Evaluation	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.
Clinical and Imaging	Radiological 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.

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

HealthCare Global Enterprises Ltd; 🇮🇳 Bangalore, Karnataka, India