Frozen Section Examination of Sentinel Lymph Nodes in Breast Cancer: A Prospective Randomized Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 142
- 试验地点
- 1
- 主要终点
- Number of participants randomized to the frozen section group and the routine histopathology group
研究概览
简要总结
This prospective randomized clinical study evaluates the role of intraoperative frozen section examination of sentinel lymph nodes in patients with breast cancer. The study aims to determine whether frozen section assessment during surgery improves intraoperative decision-making and affects surgical management when compared with standard final pathological evaluation performed after surgery.
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
- None
盲法说明
No masking is applied. Surgeons and pathologists are aware of the intraoperative frozen section assessment.
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with breast carcinoma
- •No prior neoadjuvant treatment
排除标准
- •Inability to localize the sentinel lymph node preoperatively by lymphoscintigraphy or blue dye
- •Previous axillary surgery
- •Recurrent breast cancer
- •Patients who cannot receive radiotherapy
- •Prior neoadjuvant treatment
研究组 & 干预措施
Routine Histopathology Group
Participants undergo sentinel lymph node biopsy without intraoperative frozen section. Sentinel lymph nodes are identified using blue dye and a gamma probe, then processed after formaldehyde fixation with routine histopathological evaluation. Further axillary treatment is decided according to final pathology and tumor board assessment.
干预措施: Routine Postoperative Histopathological Evaluation of Sentinel Lymph Node (Diagnostic Test)
Frozen Section Group
Participants undergo sentinel lymph node biopsy with intraoperative frozen section examination. Sentinel lymph nodes are identified using blue dye and a gamma probe, and intraoperative decision-making regarding additional axillary intervention is based on frozen section results.
干预措施: Intraoperative Frozen Section Examination of Sentinel Lymph Node (Diagnostic Test)
结局指标
主要结局
Number of participants randomized to the frozen section group and the routine histopathology group
时间窗: From first participant enrollment until the target sample size is reached, up to 1 year
Count of participants randomized by sealed-envelope method to either intraoperative frozen section evaluation of sentinel lymph nodes or routine histopathological evaluation after formalin fixation. This outcome will be reported as the total number of randomized participants until the protocol-defined target sample size for between-group comparison is reached (planned total sample size: 142 participants).
次要结局
- Percentage of participants in the routine histopathology group who require axillary lymph node dissection(From surgery until final histopathological evaluation and multidisciplinary treatment decision, up to 30 days)