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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 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
Akash Kumar Ray
All India Institute Of Medical Sciences- Jodhpur
