Feasibility Study on Delayed Selective Sentinel Node Biopsy for Patients Undergoing Mastectomy for Ductal Carcinoma in Situ
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 84
- 试验地点
- 2
- 主要终点
- success rate
研究概览
简要总结
In the case of a patient undergoing total mastectomy for intraductal carcinoma (DCIS), the sentinel lymph node is not excised during the primary surgery but only marked for identification. If the final histological examination confirms invasive cancer, delayed surgery is performed to remove the sentinel lymph node that was marked during the initial surgery.
primary endpoint : The success rate of identifying the sentinel lymph node that was marked during the primary surgery in cases where the final histological examination confirms invasive cancer is evaluated.
addendum) The previously documented Breast-Conserving Surgery has been corrected to reflect the accurate procedure of Total Mastectomy.
详细描述
Primary surgery:
Patients diagnosed with intraductal carcinoma through histological examination and scheduled for axillary lymph node dissection are included.
Prior to the surgery, blue dye and/or radioisotope injection are used to identify the sentinel lymph node, similar to the current practice.
total mastectomy surgery is performed. After identifying the sentinel lymph node in the axillary region, its location is marked using a titanium clip (size 2-4mm) or sutures (Maxon 3-0, a slow monofilament absorbable suture).
The number of marked sentinel lymph nodes is recorded for documentation.
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
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 20 to 75 years old.
- •Patients diagnosed with DCIS through histological examination.
- •Patients undergoing mastectomy
排除标准
- •In cases where the histopathological findings of the tissue examination indicate suspicious invasive lesions.
- •In cases where imaging tests or physical examinations suggest possible lymph node metastasis.
- •In patients who have previously undergone axillary lymph node surgery on the same side as the current procedure.
- •Pregnant patients.
结局指标
主要结局
success rate
时间窗: 2 weeks later
The success rate of identifying the sentinel lymph node that was marked during the primary surgery in cases where the final histological examination confirms invasive cancer is evaluated.
次要结局
未报告次要终点
研究者
Hyeong-Gon Moon
Professor
Seoul National University Hospital