| CTRI Number |
CTRI/2025/10/096012 [Registered on: 13/10/2025] Trial Registered Prospectively |
| Last Modified On: |
11/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A study on the utility of preoperative ultrasound to
locate the lateral most extent of buccal cancer |
|
Scientific Title of Study
|
A study on the utility of preoperative ultrasound to
locate the lateral most extent of buccal cancer |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Gayathri E |
| Designation |
Post Graduation |
| Affiliation |
Kovai Medical Centre and Hospital |
| Address |
Department of ENT and Head and Neck Surgery
Kovai Medical Centre and Hospital
99 Avinashi road
Coimbatore
Coimbatore
TAMIL NADU
641014
India |
| Phone |
9489433488 |
| Fax |
|
| Email |
gayathrimalu12@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dhiwakar M |
| Designation |
Consultant ENT and Head and Neck Surgeon |
| Affiliation |
Kovai Medical Centre and Hospital |
| Address |
Department of ENT and Head and Neck Surgery
Kovai Medical Centre and Hospital
99 Avinashi road
Coimbatore 641014
Tamil Nadu
India
Coimbatore
TAMIL NADU
641014
India |
| Phone |
9442250950 |
| Fax |
|
| Email |
drdhiwakar@kmchhospitals.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Dhiwakar M |
| Designation |
Consultant ENT and Head and Neck Surgeon |
| Affiliation |
Kovai Medical Centre and Hospital |
| Address |
Department of ENT and Head and Neck Surgery
Kovai Medical Centre and Hospital
99 Avinashi road
Coimbatore 641014
Tamil Nadu
India
Coimbatore
TAMIL NADU
641014
India |
| Phone |
9442250950 |
| Fax |
|
| Email |
drdhiwakar@kmchhospitals.com |
|
|
Source of Monetary or Material Support
|
| Kovai Medical Centre and Hospital
Coimbatore 641014
Tamil Nadu
India
|
|
|
Primary Sponsor
|
| Name |
Dr Gayathri E |
| Address |
Department of ENT and Head and Neck Surgery
Kovai Medical Centre and Hospital
99 Avinashi road
Coimbatore 641014
Tamil Nadu
India
|
| Type of Sponsor |
Other [SELF] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Gayathri E |
Kovai Medical Centre and Hospital |
Department of ENT and Head and Neck Surgery
99 Avinashi road
Coimbatore 641014
Tamil Nadu
India
Coimbatore
TAMIL NADU |
9489433488
gayathrimalu12@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KMCH ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C060||Malignant neoplasm of cheek mucosa, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients aged more than 18 years old undergoing primary surgical treatment for biopsy proven buccal mucosal cancer of squamous cell type staged I to IV |
|
| ExclusionCriteria |
| Details |
Carcinoma other than squamous cell carcinoma
Patient who received neoadjuvant chemotherapy
Patient with prior surgery for the index cancer
Patient with prior head and neck irradiation
Patient with primary tumor of the lip or commissure
Patient with primary tumor of the alveolus with nil or minimal involvement of the adjacent buccal
mucosa
Patient with tumor proximity less than 10 mm gross distance to the oral commissure
Patient with clinical involvement of skin or subcutaneous tissue tumor penetration or fungating
through skin skin fixity by tumor lack of skin mobility or presence of edema peau d orange or
discoloration over the tumor area |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary objective is to estimate the rate of inadequate less than or equal to 1 mm lateral margin LM with respect to other anterior
posterior superior and inferior margins in patients resected for buccal mucosal cancers as per inclusion criteria
|
It is a single point data collection study where the histopathological details are recorded and analysed during the study period |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The rate of skin resection during the surgical procedure
|
It is a single point data collection on the histopathological reports during the study period |
|
|
Target Sample Size
|
Total Sample Size="18"
Sample Size from India="18"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/11/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response (Others) -
- For how long will this data be available start date provided 01-01-2028 and end date provided 01-01-2032?
Response (Others) -
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Buccal cancers have a higher risk of inadequate surgical margins especially at the lateral margin which strongly predicts local recurrence This occurs due to the difficulty in assessing tumor extent and surgeons tendency to preserve uninvolved cheek skin Although CT MRI and USG have been used to plan skin resection their effect on the histopathologic adequacy of the LM is unclear This prospective study evaluated whether preoperative USG could accurately map the lateral most tumor extent guide surgeons to high risk areas and reduce the rate of inadequate less than or equal to 1 mm lateral margins Patients with buccal squamous cell carcinoma undergoing primary surgery at KMCH were included those with prior treatment neoadjuvant chemotherapy, prior surgery for the index cancer prior head and neck irradiation primary tumor of the alveolus non squamous cancers lip and commissure primaries or skin involvement were excluded Each patient underwent preoperative USG mapping by a head and neck radiologist The most lateral location of the tumor assessed and the corresponding area marked on the skin with plaster and the circumferential border of the plaster would be marked on the skin by methylene blue tattoo and the plaster removed before surgery Surgeons aimed for greater than or equal to 10 mm gross margins paying special attention to the marked lateral area and extending resection including skin if needed After resection specimens were oriented and labeled and margins were measured in five planes anterior posterior superior inferior and lateral deep plane nearest the skin Chi square test used to examine the categorical data to estimate the rate of inadequate lateral margin less than or equal to 1 mm compared with the other surgical margins anterior posterior superior and inferior and to compare the rate of inadequate margin less than or equal to 1 mm within the marked lateral resection area target LM with respect to the rest of the area on the lateral resection plane outside target lateral margin |