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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-100
SponsorDr.Pankaj Chaturvedi

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

Multifocal disease

Clinically evident field cancerization

Previous treatment for oral cavity cancer - Surgery /chemo or radiotherapy -

Trial design

Treatments tested in this trial

  • Gross examination of the resection specimen
  • Frozen section

Treatment groups

1,206 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Dr.Pankaj Chaturvedi

Lead sponsor

Tata Memorial Centre

Sponsor institution