Gross examination of the resection specimen
Proceduremeasurement of the surgical margin by the operating surgeon using sterile scale, margins <7mm will be revised on table
NCT Number: NCT04809324
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.
Interested in participating?
Request Info18 year–100 year
All sexes
Interventional
Not applicable
Tata Memorial Hospital, Mumbai, Maharashtra, India
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
measurement of the surgical margin by the operating surgeon using sterile scale, margins <7mm will be revised on table
frozen section evaluation of the specimen by the pathologist
Time frame: 2 years
To determine the difference between the local recurrence free survival (LRFS) between intra operative gross examination by the surgeon compared with microscopic examination using frozen sections by the pathologist for the assessment of surgical margin in patients undergoing surgery for OCSCC.
Local recurrence will be defined as - tumor recurrence at the same subsite or or at margins of previous surgery &/ reconstruction with or without nodal recurrence /distant metastases withing two years after completion of the treatment.
Time frame: 5 years
To determine the accuracy of intra operative gross examination by the surgeon compared with microscopic examination of frozen sections by the pathologist for the assessment of surgical margin as compared to the final histopathology report as the gold standard.
Time frame: 5years
Contact information is provided by the study sponsor or research team.
Pankaj Chaturvedi, MS
CONTACT
Vidisha V Tuljapurkar, MS MCh
CONTACT
Dr.Pankaj Chaturvedi
Other
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
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