Sentinel Node Biopsy Versus Limited Elective Neck Dissection in Early Cancers of Oral Cavity NoDe Negative

NARecruitingINTERVENTIONAL
Enrollment

508

Participants

Timeline

Start Date

April 16, 2025

Primary Completion Date

April 30, 2032

Study Completion Date

April 30, 2034

Conditions
Mouth NeoplasmsOral CancersOral Squamous Cell Carcinoma (OSCC)Oral Squamous Cell CarcinomasSentinel Lymph Node BiopsySentinel Lymph Node Biopsy (SLNB)Sentinel Lymph Node
Interventions
PROCEDURE

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.

PROCEDURE

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.

Trial Locations (3)

400012

RECRUITING

Tata Memorial Hospital, Mumbai

Unknown

NOT_YET_RECRUITING

ACTREC, Navi Mumbai

NOT_YET_RECRUITING

Mpmmcc & Hbch, Varanasi

All Listed Sponsors
collaborator

Tata Memorial Centre

OTHER

lead

Tata Memorial Hospital

OTHER_GOV