508
Participants
Start Date
April 16, 2025
Primary Completion Date
April 30, 2032
Study Completion Date
April 30, 2034
Sentinel Node Biopsy
The Sentinel node will be localized after injecting peritumoral nano colloid followed by dynamic lymphoscintigraphy and SPECT localization. Methylene blue or indocyanine green may be used but not mandatory as an adjunct for lymphoscintigraphy for node localization. Intraoperatively the node will be identified using a hand-held gamma probe. The sentinel node will be processed on a frozen section, histopathological processing with serial step sectioning, and immunohistochemistry. If reported as metastatic, then a single-stage or second-stage completion neck dissection will be performed.
Limited Elective Neck Dissection
Patients who are allocated to the limited END arm will undergo dissection of level I, IIa and III/IV nodes sparing level IIb. Level IIa will be subjected to a frozen section and if reported as metastatic will mandate clearance of level IIb.
RECRUITING
Tata Memorial Hospital, Mumbai
NOT_YET_RECRUITING
ACTREC, Navi Mumbai
NOT_YET_RECRUITING
Mpmmcc & Hbch, Varanasi
Tata Memorial Centre
OTHER
Tata Memorial Hospital
OTHER_GOV