跳至主要内容
临床试验/CTRI/2025/11/097482
CTRI/2025/11/097482尚未招募不适用

The Role of Sentinel Lymph Node Biopsy In Detecting Occult Contralateral Neck Nodal Metastasis in Midline Approaching Oral Squamous Cell Carcinoma- A Prospective Validation Study

AIIMS Jodhpur1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2026年1月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
AIIMS Jodhpur
入组人数
45
试验地点
1

研究概览

简要总结

Population: 18 to 70 years

Intervention: Peritumoral injection of a radiotracer or dye will be performed, followed by lymphoscintigraphy and intraoperative sentinel lymph node biopsy (SLNB) using advanced imaging and a gamma probe to detect sentinel lymph nodes, particularly in the contralateral neck.

Comparison: N/A

Outcome: The primary outcome is the sensitivity of SLNB in detecting contralateral lymph node metastasis in OSCC cases approaching or crossing the midline. Secondary outcomes include the identification rate of contralateral lymph node metastasis, specificity, false negative rates, and mapping patterns of contralateral lymphatic drainage.

Time: N/A (single point assessment during surgery)

Research Question: Can contralateral neck dissection be avoided with the help of SLNB in lesions approaching midline?

This study aims to assess the effectiveness of SLNB and lymphatic mapping in identifying contralateral cervical lymph node metastasis in midline approaching OSCC (MOSCC) with sensitivity as the primary and identification rate, specificity, false negative rate, and lymphatic drainage patterns of the contralateral neck as secondary objectives

Inclusion Criteria: Histologically proven OSCC approaching midline In ages 18-70 years with contralateral negative neck with curative intent surgery

Exclusion Criteria: Synchronous/recurrent head and neck tumors, previously irradiated/ surgically explored neck and proven contralateral nodal disease

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • Histologically proven Oral SCC approaching or crossing midline or with bulky ipsilateral nodal disease, in patients aged 18- 70 years and clinically or radiologically proven contralateral N0 undergoing surgery with curative intention.

排除标准

  • Synchronous tumours in Head and Neck region Previous history of neck dissection or irradiation Burns over neck and face Clinically/Radiologically Contralateral N+ Recurrent disease.

研究者

发起方
AIIMS Jodhpur
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Akash Kumar Ray

All India Institute Of Medical Sciences- Jodhpur

研究点 (1)

Loading locations...

相似试验