Diagnostic Accuracy of Preoperative Ultrasonographic Tattooing of Suspicious Axillary Lymph Nodes in Breast Cancer Patients With Clinically Negative Axilla. A Prospective Cohort Study.
试验速览
- 阶段
- 不适用
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- Identification benefit of the ultrasonographical tattooing.
研究概览
简要总结
Breast cancer is the most common cancer of women. Surgery for early breast cancer includes axillary lymph nodes staging. Axillary surgery may lead to intractable complications like permanent arm swelling. Axillary sentinel lymph node biopsy (SLNB) has been introduced to minimize the incidence of these complications. Several methods are routinely used for identification of the sentinel node during operation. Some of these methods necessitate facilities that are not universally available; specially in countries with limited resources. In its simplest form, SLNB using the methylene blue dye technique has an identification rate of 88-94%. If the sentinel node can not be identified, full axillary dissection may be required and the risk of arm swelling is increased. The objective of this study is to maximize the identification rate of the sentinel node thus avoiding the need for extensive axillary surgery. The investigators assumed that preoperative tattooing of the suspicious lymph node during ultrasonographical imaging may help the surgeon in localizing the sentinel lymph node. In this study, the sonographer will perform preoperative tattooing of the suspicious node. The surgeon will perform SLNB by the methylene blue dye. The sensitivity of ultrasonographical tattooing relative to SLNB will be calculated. The study will determine if the tattooing technique may localize additional nodes that are missed by the methylene blue.
详细描述
Introduction Axillary nodal staging is an integral part of breast cancer management. Sentinel lymph node biopsy (SLNB) has become a standard of care in patients with clinically negative axillae. Various methods have been investigated to decrease the false negative rate of SLNB. Ultrasonography is an established tool for preoperative axillary staging. The diagnostic accuracy of B-mode ultrasonographic criteria and of US-guided FNAC (Fine Needle Aspiration Cytology) has been described in the literature and its role in preoperative axillary staging has been emphasized.
Ultrasonographic aspiration of suspicious axillary nodes are widely used to identify axillary metastases and obviate the need for SLNB. Previous studies retrospectively examined the concordance of ultrasonographic identification of suspicious lymph nodes with subsequent SLNB results. However, ultrasonographic axillary staging have not been prospectively compared to SLNB. In addition, concomitant ultrasonographic and SLNB are thought to increase the overall accuracy of axillary staging.
In this study, the investigators will perform preoperative ultrasonographic axillary evaluation and tattooing of suspicious lymph nodes followed by SLNB with methylene blue technique. Head-to-head and node-to-node comparison of ultrasonographic and surgical staging will be conducted.
Specific aims
- Determination of the diagnostic accuracy of preoperative ultrasonic guided tattooing of suspicious axillary lymph nodes.
- Determination of node-to-node concordance of ultrasonographic tattooing relative to blue dye SLNB.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Biopsy-proven invasive breast adenocarcinoma.
- •Clinically non palpable axillary lymph nodes.
- •T0-3, N0, M0
- •Scheduled for definitive surgery.
排除标准
- •Patient unwilling to participate.
- •Contraindication to methylene blue technique: hypersensitivity, pregnancy.
- •T4 primary tumor.
- •Previous axillary surgery.
结局指标
主要结局
Identification benefit of the ultrasonographical tattooing.
时间窗: at the date of surgery.
The ratio of the cases with successfully tattooed nodes and non identified sentinel node to the total number of analyzed cases.
Sensitivity of ultrasonographical tattooing
时间窗: at the date of surgery.
The ratio of the tattooed lymph nodes (that are positive by histopathological examination) to the sentinel lymph nodes (that are positive by histopathological examination).
次要结局
未报告次要终点
研究者
Osama Hussein
Professor of Surgery
Mansoura University