RecruitingNot ApplicableNCT04809324

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

Intra-operative Gross Examination Versus Frozen Section for Achievement of Adequate Margin in Patients Undergoing Surgery for Oral Cavity Squamous Cell Carcinoma: A Randomized Controlled Trial


Sponsor

Dr.Pankaj Chaturvedi

Enrollment

1,206 participants

Start Date

Nov 15, 2021

Study Type

INTERVENTIONAL

Conditions

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 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

Min Age: 18 YearsMax Age: 100 Years

Inclusion Criteria4

  • 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 Criteria3

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

Interventions

PROCEDUREGross examination of the resection specimen

measurement of the surgical margin by the operating surgeon using sterile scale, margins \<7mm will be revised on table

PROCEDUREFrozen section

frozen section evaluation of the specimen by the pathologist


Locations(3)

Tata Memorial Hospital

Mumbai, Maharashtra, India

ACTREC,Advanced Centre for Treatment, Research and Education in Cancer

Navi Mumbai, Raigad, India

Mahamana Pandit Madan Mohan Malaviya Cancer Centre

Varanasi, Uttar Pradesh, India

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NCT04809324


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