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临床试验/NCT05950737
NCT05950737已完成不适用

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

Tata Memorial Hospital2 个研究点 分布在 1 个国家目标入组 115 人开始时间: 2021年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
115
试验地点
2
主要终点
Diagnostic accuracy of the SNB

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

结局指标

主要结局

Diagnostic accuracy of the SNB

时间窗: Through study completion, an average of 2 year

Sensitivity, specificity, negative predictive value, positive predictive value, False negative rate, SNB identification rate

次要结局

  • To study the pattern of metastasis in sentinel and non-sentinel nodes(Through study completion, an average of 2 year)

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Richa Vaish

Professor

Tata Memorial Hospital

研究点 (2)

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