Evaluation of Tumor Bed Cavity Shaving as an Oncologically Safe Alternative to Frozen Section Analysis in Breast-Conserving Surgery
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Rate of positive margins and re-excision within 2 years post-surgery
研究概览
简要总结
Evaluation of Tumor Bed Cavity Shaving as an Oncologically Safe Alternative to Frozen Section Analysis in Breast-Conserving Surgery and aim of study To assess the oncological safety and practicality of tumor bed cavity shaving also aims to evaluate its impact on operative time and overall cost.
详细描述
Breast cancer remains the most common malignancy among women worldwide and represents a major health burden. Breast-conserving surgery (BCS) has become the standard of care for early-stage breast cancer, aiming to achieve complete tumor excision with histologically clear margins combined with adjuvant radiotherapy, offers equivalent survival rates to mastectomy in early-stage cases.
. Positive surgical margins are strongly associated with increased rates of local recurrence and frequently necessitate re-excision.
Traditionally, intraoperative frozen section analysis (FSA) has been used to assess margin status. However, this technique has several drawbacks, including:
-
Limited availability in many centers.
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Requires high-experienced cytopathologists making it challenging in resource-limited places.
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Adds substantial cost.
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Time consuming (prolonged operative time).
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Recently, the tumor bed cavity shaving (TBCS) has been introduced as a more practical alternative technique that can reduce the incidence of positive margins without relying on intraoperative pathology.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients aged ≥18 years.
- •Diagnosed with unifocal, operable invasive breast carcinoma.
- •Suitable for breast-conserving surgery. Criteria:
排除标准
- •Contraindication of Breast-Conserving Surgery.
研究组 & 干预措施
Tumor bed cavity shaving arm
Patients undergoing breast-conserving surgery will receive intraoperative tumor bed cavity shaving as an alternative approach to ensure clear surgical margins. Additional cavity shavings will be taken circumferentially after the primary lumpectomy specimen. The outcomes will be compared with standard margin assessment methods.
干预措施: Tumor bed cavity shaving (Procedure)
结局指标
主要结局
Rate of positive margins and re-excision within 2 years post-surgery
时间窗: From time of enrollment of the patient until 2 years post-operative
Percentage of patients whose surgical pathology shows positive margins, and percentage of patients who undergo re-excision. Assessment will be based on histopathology reports and surgical records. Unit of Measure: percentage number of patients Measurement Tool: Histopathological examination (pathology report) for margin status; surgical database/operative logs for re-excision events.
次要结局
- - Cost-effectiveness - Facilities availability - Impact on intraoperative time(From enrollment time of the patient until 2 years post operative)
研究者
Mark Ezzat Gerges
Resident Physician at General surgery department Assiut University Hospital
Assiut University