A Novel Technique for Preoperative Localization of Sentinel Lymph Node in Breast Cancer Patients by Silver Wire Insertion or Liquid Charcoal Injection Guided by CT Lymphography
试验速览
- 阶段
- 1 期
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- detection of the sentinel lymph node by the novel method & matching between the sentinel lymph node detected by the novel method and the control one
研究概览
简要总结
A question is raised about the possibility of accurate localization of the SLN (sentinel lymph node) detected by CTLG (Computed Tomography Lymphography) which offers a detection rate of 100% in many studies In Oncology center, Mansoura University (OCMU), the surgical oncology unit had a previous experience in using charcoal for localization of non-palpable suspicious breast lesions and it showed promising results in comparison to traditional localization methods In addition, we had another study using silver wire for localization of breast masses before neoadjuvant therapy.
In the study, the investigators will study the usage of both methods as preoperative localization methods for the SLN detected by CT lymphography in breast cancer patients The investigators suppose that this method can offer two main advantages over the traditional SLN intraoperative methods which are; saving operative time needed for the intraoperative procedure as well as solving the problem of the need for complex logistic preparations especially for the usage of radioisotope method.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Participant)
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •node negative early breast cancer
排除标准
- •• Unfit patients for general anaesthesia
- •Previous axillary surgery
- •History of breast surgery or incisional biopsy compromising the breast lymphatic drainage.
- •Known hypersensitivity to the dye
- •Patients with clinically positive or suspicious axilla
- •Pregnant females
研究组 & 干预措施
charcoal
干预措施: preoperative localization of SLN detected by CTLG by either methods (Device)
silver wire
干预措施: preoperative localization of SLN detected by CTLG by either methods (Device)
结局指标
主要结局
detection of the sentinel lymph node by the novel method & matching between the sentinel lymph node detected by the novel method and the control one
时间窗: one year
次要结局
未报告次要终点
研究者
Omar Hamdy
Principal investigator, Assistant lecturer of surgical oncology
Mansoura University
