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

  • STATUS
    Recruiting
  • End date
    Jun 12, 2028
  • participants needed
    1206
  • sponsor
    Dr.Pankaj Chaturvedi
Updated on 12 May 2022

Summary

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 resourcepoor 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.

Details
Condition Oral Cavity Cancer
Treatment Gross examination of the resection specimen, Frozen section, Frozen section
Clinical Study IdentifierNCT04809324
SponsorDr.Pankaj Chaturvedi
Last Modified on12 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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