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Gross Examinations Versus Frozen Section for Assessment of Surgical Margins in Oral Cancers
Study Purpose
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.Recruitment Criteria
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
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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 Details
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
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The disease, disorder, syndrome, illness, or injury that is being studied.
Arms
Experimental: Gross examination
measurement of the surgical margins will be done by the surgeon in the operating room using sterile scale after resection of the primary tumor .
Active Comparator: Frozen section
frozen section examination of surgical margins will be done by the pathologist.
Interventions
Procedure: - Gross examination of the resection specimen
measurement of the surgical margin by the operating surgeon using sterile scale, margins <7mm will be revised on table
Procedure: - Frozen section
frozen section evaluation of the specimen by the pathologist
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
International Sites
Status
Recruiting
Address
Tata Memorial Hospital
Mumbai, Maharashtra, 400012
Site Contact
Pankaj Chaturvedi, MS
[email protected]
+91 9869486912
Status
Not yet recruiting
Address
ACTREC,Advanced Centre for Treatment, Research and Education in Cancer
Navi Mumbai, Raigad, -410210
Site Contact
Sudhir Nair, MS
[email protected]
9769617780
Status
Not yet recruiting
Address
Mahamana Pandit Madan Mohan Malaviya Cancer Centre
Varanasi, Uttar Pradesh, 221005
Site Contact
Assem Mishra, MS,MCh
[email protected]
8080611946
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