Gross Examinations Versus Frozen Section for Assessment of Surgical Margins in Oral Cancers

Dr.Pankaj Chaturvedi

Status: Enrolling

Conditions: Oral Cavity Cancer

Treatments: Procedure: Frozen section; Procedure: Gross examination of the resection specimen

Study type: Interventional

Funder types: Other

Identifiers

NCT04809324

protocol no 3541

CTRI/2021/03/032015 (Registry Identifier)

Details and patient eligibility

About

Surgical margin is a significant prognostic factor in oral cavity squamous cell carcinoma (OCSCC)[1,2,3]. Intra-operative frozen section (FS) has been routinely used by the surgeons to achieve adequate surgical margins. However published literature has failed to show a conclusive benefit of FS in improving oncological outcomes(4-7). The overall identification rate of the inadequate margins by FS is variable with figures in the literature ranging from25-34%.(8-10)

Revision of margins based on FS is widely practiced in centers where facility for FS is available. However this has not shown to significantly improve local control when compared to cases in which FS was not utilized , in a comparative study done at Tata memorial Hospital(TMH) (5) More-over FS is a costly procedure, and sparsely available in resource- poor countries. In a recently conducted retrospective study of 1237 patients conducted at TMH, the cost benefit ratio of FS for assessment of margin is as low as 12:1(11). In another prospective study performed at the same center , investigators found that gross examination (GE) of margins by the surgeons was as effective as FS, and achievement of gross 7mm margin all around the tumor obviated the need for FS (12). In a recent meta-analysis of 8 studies that looked at the utility of frozen section and had uniformity in frozen section analysis and definition of close margins, they concluded that revision of margins based on FS does not improve oncological outcomes and further prospective studies are needed to explore this contentious issue (13). With this background, a prospective RCT is planned to explore if gross examination by surgeon and subsequent revision of margin (if necessary) is an equally effective alternative to Frozen section based revision in a randomized controlled trial.

Enrollment: 1,206 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Biopsy proven treatment naïve cases of OCSCC who are planned for curative surgery with en-bloc removal of the tumor with adequate margin
2. In detail assessment of the primary tumor is possible pre-operatively
3. Written informed consent
4. Age more than 18 years

Exclusion criteria

1. Multifocal disease
2. Clinically evident field cancerization
3. Previous treatment for oral cavity cancer - Surgery /chemo or radiotherapy -

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,206 participants in 2 patient groups

Gross examination

Experimental group

Description:

measurement of the surgical margins will be done by the surgeon in the operating room using sterile scale after resection of the primary tumor .

Treatment:

Procedure: Gross examination of the resection specimen

Frozen section

Active Comparator group

Description:

frozen section examination of surgical margins will be done by the pathologist.

Treatment:

Procedure: Frozen section