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Sentinel Node Biopsy in Early Oral Cancers a Tertiary Cancer Centre Experience

Sentinel Node Biopsy in Early Oral Cancers a Tertiary Cancer Centre Experience

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05950737
Enrollment
115
Registered
2023-07-18
Start date
2021-06-01
Completion date
2024-07-31
Last updated
2024-10-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oral Cavity Squamous Cell Carcinoma

Keywords

oral neoplasm, sentinel node biopsy, node negative

Brief summary

Sentinel node biopsy is a suitable alternative to END and is recommended in standard guidelines. Investigators have been doing SNB in their department to standardize the process for the last two years. This study aims to analyze the diagnostic accuracy of the SNB performed to standardize the procedure at their institute.

Detailed description

Elective neck dissection (END) is the standard of care in node-negative early oral cancers. However, it is associated with morbidity predominantly of shoulder dysfunction. Moreover, nearly 55-70% are true node-negative and are over-treated with this approach. Attempts have been made to overcome this limitation and to identify true node-negative patients. Sentinel node biopsy has shown the highest diagnostic accuracy among all other options. The SN is the first echelon node that drains directly through the lymphatics from the primary tumour. The principle of SNB is based on the fact that since it is the first echelon node, it would be the first site of regional metastasis. Therefore, the metastasis is unlikely to involve other nodal levels if the SNB is negative. It is the standard of care in breast cancers and melanoma. The concept made its way into oral cavity tumours and has been explored for over a decade in this setting. The results of the multi-institutional trial by Civantos et al. reported a high NPV of 94% of this procedure in early oral cancers that were node negative. Since then, various meta-analyses have shown that SNB has a high NPV making it a strong diagnostic modality. Schilling et al. reported the 3-year results of SNB in oral cancers in a multicentric study comprising 415 patients. The authors successfully identified the SN in 99.5% of cases and reported an FNR of 14%, which was high. Despite this, the study showed a high 3-year-disease-specific survival of 94%. Recently published Phase III Randomized controlled trials have shown that the overall survival of sentinel node biopsy is comparable to END with lesser morbidity in shoulder dysfunction. The advantage of the procedure is that only 25-30% of the patients who are SNB positive need to undergo neck dissection, and it spares unnecessary neck clearance and hence limits the morbidity in the remaining 70-75% of cases. SNB is a suitable alternative to END and is recommended in standard guidelines. However, SNB has a learning curve, it is recommended that the process be standardized, and the team should perform adequate SNB, followed by the completion of neck dissection before sparing the neck based on SNB. Investigators have been doing SNB in their department to standardize the process following the publication of level I evidence. This study aims to analyze the diagnostic accuracy of the SNB performed to standardize the procedure at the investigator's institute.

Interventions

All patients have undergone completion neck dissection following SNB in the process of standardization.

Sponsors

Tata Memorial Hospital
Lead SponsorOTHER_GOV

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

1. Age between 18 to 75 years of age, 2. Biopsy-proven invasive squamous cell carcinoma involving site among tongue and buccal mucosa 3. T1 and T2 lesions as per AJCC TNM classification 4. Clinicoradiologically node negative 5. Amenable to per oral excision

Exclusion criteria

1. Upper alveolar or palatal lesions 2. Large heterogeneous leukoplakia or other premalignant lesion 3. T3/T4 lesions 4. Lesions requiring raising of cheek flap to access for excision

Design outcomes

Primary

MeasureTime frameDescription
Diagnostic accuracy of the SNBThrough study completion, an average of 2 yearSensitivity, specificity, negative predictive value, positive predictive value, False negative rate, SNB identification rate

Secondary

MeasureTime frameDescription
To study the pattern of metastasis in sentinel and non-sentinel nodesThrough study completion, an average of 2 yearLevel-wise frequency of SN metastasis, Frequency of metastasis in the SN basin, Frequency of metastasis to extra sentinel nodal basin

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026