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

Buccal Mucosa Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03137953
• Other study ID #: HCG/SX/002/2016
• Status: Recruiting
• Phase: N/A
• First received: February 13, 2017
• Last updated: May 8, 2017
• Start date: June 1, 2016
• Est. completion date: June 30, 2017

Study information

• Verified date: May 2017
• Source: HealthCare Global Enterprise Ltd.
• Contact: Vishal US Rao, MS
• Phone: 9739774949
• Email: drvishalrao[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: June 30, 2017
• Est. primary completion date: June 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Buccal Mucosa Cancer
• Gingival Cancer

Intervention

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.

Locations

Country	Name	City	State
India	HealthCare Global Enterprises Ltd	Bangalore	Karnataka

Sponsors (1)

Lead Sponsor	Collaborator
HealthCare Global Enterprise Ltd.

Country where clinical trial is conducted

India, 

References & Publications (3)

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. Epub 2006 Mar 10. — View 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. Epub 2006 Feb 2. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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