Clinical trial NCT03137953: Role of Imaging to Predict the Deep Surgical Margin in Gingivobuccal Complex Tumors
Official title: Role of Imaging to Predict the Deep Surgical Margin in Gingivobuccal Complex Tumors
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Buccal Mucosa Cancer
Gingival Cancer
Lead sponsor: HealthCare Global Enterprise Ltd.
Sponsor class: INDUSTRY
First posted: 2017-05-03
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Proportion of patients undergoing skin preservation surgeries
timeFrame: Data would be obtained on the day of Surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Bangalore
country: India
facility: HealthCare Global Enterprises Ltd
state: Karnataka
Study officials:
affiliation: Dept of Head & Neck Surgery, HealthCare Global Enterprises Ltd.
name: Vishal US Rao, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ota Y, Aoki T, Karakida K, Otsuru M, Kurabayashi H, Sasaki M, Nakamura N, Kajiwara H. Determination of deep surgical margin based on anatomical architecture for local control of squamous cell carcinoma of the buccal mucosa. Oral Oncol. 2009 Jul;45(7):605-9. doi: 10.1016/j.oraloncology.2008.08.010. Epub 2008 Nov 20.
citation: Liao CT, Wang HM, Ng SH, Yen TC, Lee LY, Hsueh C, Wei FC, Chen IH, Kang CJ, Huang SF, Chang JT. Good tumor control and survivals of squamous cell carcinoma of buccal mucosa treated with radical surgery with or without neck dissection in Taiwan. Oral Oncol. 2006 Sep;42(8):800-9. doi: 10.1016/j.oraloncology.2005.11.020. Epub 2006 Feb 2.
citation: Coppen C, de Wilde PC, Pop LA, van den Hoogen FJ, Merkx MA. Treatment results of patients with a squamous cell carcinoma of the buccal mucosa. Oral Oncol. 2006 Sep;42(8):795-9. doi: 10.1016/j.oraloncology.2005.11.017. Epub 2006 Mar 10.