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

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.

Study Overview

• Status: Unknown
• Conditions: Buccal Mucosa Cancer; Gingival Cancer
• Intervention / Treatment: Procedure: Clinical Evaluation; Diagnostic test: Radiological Imaging

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 Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Karnataka
    • Bangalore, Karnataka, India, 560027
      • Recruiting
      • Healthcare Global Enterprises Ltd
      • Contact: Vishal US Rao, MS; Phone Number: 00919739774949; Email: drvishalrao@yahoo.com
      • Contact: Sataksi Chatterjee, MS; Phone Number: 00918971966903; Email: sataksis2007@gmail.com
      • Sub-Investigator: Sowjanya Gandla, MS
      • Sub-Investigator: Shivakumar Swamy, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: 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.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients undergoing skin preservation surgeries	Proportion of subjects who are to undergo skin preservation surgeries	Data would be obtained on the day of Surgery

Collaborators and Investigators

• Sponsor: HealthCare Global Enterprise Ltd.
• Investigators: Principal Investigator: Vishal US Rao, MS, Dept of Head & Neck Surgery, HealthCare Global Enterprises Ltd.

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 1, 2016
• Primary Completion (ANTICIPATED): June 30, 2017
• Study Completion (ANTICIPATED): June 30, 2017

Study Registration Dates

• First Submitted: February 13, 2017
• First Submitted That Met QC Criteria: April 28, 2017
• First Posted (ACTUAL): May 3, 2017

Study Record Updates

• Last Update Posted (ACTUAL): May 9, 2017
• Last Update Submitted That Met QC Criteria: May 8, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: HCG/SX/002/2016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO