Methylene blue dye in the evaluation of the primary draining lymph nodes in localised, node-negative oral cavity cancer: a prospective study from a tertiary cancer center.
Not Applicable
Not yet recruiting
- Conditions
- Health Condition 1: C060- Malignant neoplasm of cheek mucosa
- Registration Number
- CTRI/2022/01/039523
- Lead Sponsor
- Kidwai Memorial Institute of Oncology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Consecutive patients with biopsy proven, upfront operable SCC of the buccal mucosa, with no clinical or radiological evidence of cervical lymphadenopathy.
Exclusion Criteria
Patients who were under 18 years of age, oral cavity subsites other than buccal mucosa, with prior history of head and neck surgery, recurrent oral cancer or any form of neoadjuvant therapy, patients with palpable lymphadenopathy and those who did not consent to the procedure
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pattern of lymph nodal spread in buccal mucosa SCC <br/ ><br>SLN identification rate with blue dye <br/ ><br>The accuracy (including the true positive and false negative rate) of blue dye in predicting the nodal status of the neck.Timepoint: 8 weeks (at study completion)
- Secondary Outcome Measures
Name Time Method Incidence of nodal metastases in clinically node negative SCC of the buccal mucosa <br/ ><br>Identification and correlation of tumor factors predictive of nodal involvement.Timepoint: 4 weeks